| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
| AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984) | Assure Tech., LLC | 2026-07-17 |
| BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (K260065) | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 |
| Healgen® Accurate Oral Fluid Drug Test (K253705) | Healgen Scientific,, LLC | 2026-03-16 |
| Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (K260355) | WEBEST Biotech,, LLC | 2026-03-09 |
| Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (K252523) | Healgen Scientific,, LLC | 2026-02-12 |
| Labcorp Fentanyl Urine Visual Test (K252684) | Medtox Diagnostics, Inc. | 2026-01-29 |
| Evidence MultiSTAT DOA Urine MultiPlex (K250741) | Randox Laboratories Limited | 2026-01-23 |
| LZI Buprenorphine II Enzyme Immunoassay (K253082) | Lin-Zhi International, Inc. | 2026-01-16 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K253567) | Healgen Scientific,, LLC | 2025-12-23 |
| Fenom Flo™ FeNO Monitoring System (K251674) | Mgc Diagnostics Corporation | 2025-11-26 |
| SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (K252550) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 |
| VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (K252867) | Advin Biotech, Inc. | 2025-10-09 |
| Sober Self-Test (K250609) | Sober Ip, LLC | 2025-09-15 |
| Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (K252554) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| Vivatmo pro-S (K243926) | Bosch Healthcare Solutions GmbH | 2025-09-11 |
| SEFRIA™ Hydrocodone Oral Fluid (K252520) | Immunalysis Corporation | 2025-09-11 |
| CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 |
| AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259) | Assure Tech., LLC | 2025-08-15 |
| Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972) | Healgen Scientific,, LLC | 2025-08-15 |
| Diazyme Colorimetric Lithium Assay (K243462) | Diazyme Laboratories, Inc. | 2025-08-01 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| LZI Fentanyl III Enzyme Immunoassay (K251634) | Lin-Zhi International, Inc. | 2025-06-18 |
| Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (K250803) | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (K250727) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| LYHER® Oral fluid Multi-Drug Test Kit (Cube) (K240287) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 |
| AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (K244043) | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 |
| Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (K243996) | Assure Tech., LLC | 2025-02-07 |
| Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (K242428) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 |
| Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (K243365) | Healgen Scientific,, LLC | 2024-12-17 |
| Alinity c Benzodiazepines Reagent Kit (K243498) | Microgenics Corporation | 2024-12-11 |
| ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (K243064) | Eterbio, Inc. | 2024-11-20 |
| CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (K242802) | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 |
| DRI Ecstasy Plus Assay (K240670) | Microgenics Corporation | 2024-10-30 |
| BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (K242498) | Aicheck Biotech, Inc. | 2024-10-01 |
| AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (K242540) | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 |
| PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup (K242077) | Aicheck Biotech, Inc. | 2024-08-14 |
| Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969) | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 |
| SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel (K241741) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 |
| AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (K241428) | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 |
| BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (K240124) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 |
| Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (K241100) | Co-Innovation Biotech Co., Ltd. | 2024-05-22 |
| Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) (K240949) | Healgen Scientific,, LLC | 2024-05-13 |
| Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (K240698) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K240686) | Healgen Scientific,, LLC | 2024-04-12 |
| SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (K240654) | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-04-10 |
| InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) (K240295) | Instanosis, Inc. | 2024-03-28 |
| AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test (K234006) | Allsource Screening Solutions | 2024-03-21 |
| Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (K231904) | Co-Innovation Biotech Co., Ltd. | 2024-03-08 |
| FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) (K240351) | Assure Tech., LLC | 2024-03-06 |
| ARK Levetiracetam II Assay (K232522) | Ark Diagnostics, Inc. | 2024-02-27 |
| Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (K232228) | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 |
| Vivatmo pro (K233775) | Bosch Healthcare Solutions GmbH | 2024-02-22 |
| Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 (K232732) | Co-Innovation Biotech Co., Ltd. | 2024-01-17 |
| LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (K232604) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-10 |
| LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) (K232597) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test (K232736) | Chemtron Biotech, Inc. | 2023-12-20 |
| Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (K232659) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 |
| AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019) | Hangzhou AllTest Biotech Co., Ltd. | 2023-12-13 |
| Alinity c Tricyclic Antidepressants Reagent Kit (K231020) | Microgenics Corporation | 2023-11-17 |
| ARK Hydrocodone Assay (K231752) | Ark Diagnostics, Inc. | 2023-11-09 |
| BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (K233062) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 |
| AllTest Fentanyl Urine Test Cassette (K233417) | Hangzhou AllTest Biotech Co., Ltd. | 2023-10-26 |
| Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (K220451) | Randox Laboratories Limited | 2023-10-05 |
| Evidence MultiSTAT DOA Urine MultiPlex (K221550) | Randox Laboratories Limited | 2023-10-05 |
| Procise ADL (DEN220023) | Procisedx, Inc. | 2023-09-29 |
| Procise IFX (DEN210056) | Procisedx, Inc. | 2023-09-29 |
| CEDIA Heroin Metabolite (6-AM) Assay (K231007) | Microgenics Corporation | 2023-09-27 |
| BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 (K231978) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 |
| Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439) | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 |
| AllTest Fentanyl Rapid Test (Urine) (K231698) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 |
| Emit® II Plus Buprenorphine Assay (K221605) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| Fenom Pro (K213611) | Caire Diagnostics, Inc. | 2023-06-07 |
| Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K231137) | Xenta Biomedical Science Co., Ltd. | 2023-05-19 |
| BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx (K230238) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 |
| ONLINE TDM Phenytoin - Free Phenytoin application (K230161) | Roche Diagnostics | 2023-03-30 |
| Genomadix Cube CYP2C19 System (K220026) | Genomadix, Inc. | 2023-03-21 |
| Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162) | Healgen Scientific,, LLC | 2023-03-17 |
| Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K222955) | Xenta Biomedical Science Co., Ltd. | 2023-02-06 |
| ONLINE DAT Benzodiazepines II (K221765) | Roche Diagnostics | 2022-12-23 |
| DRI TM Tricyclics Serum Tox Assay (K213875) | Microgenics Corporation | 2022-12-21 |
| Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (K220046) | Shenzhen Superbio Technology Co., Ltd. | 2022-12-13 |
| Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (K222667) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 |
| Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx (K221871) | Healstone Biotech, Inc. | 2022-08-30 |
| Immunalysis Tapentadol Urine HEIA (K203527) | Lmmunalysis Corporation | 2022-05-09 |
| HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx (K220685) | Qingdao Hightop Biotech Co., Ltd. | 2022-05-05 |
| Acetaminophen (K202644) | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 |
| Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System (K213211) | Carolina Liquid Chemistries Corp. | 2022-01-27 |
| SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (K203564) | Immunalysis Corporation | 2021-12-22 |
| SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (K203647) | Immunalysis Corporation | 2021-12-22 |
| NObreath® (K203695) | Bedfont Scientific, Ltd. | 2021-12-17 |
| Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (K210212) | Psychemedics Corporation | 2021-12-15 |
| DRI Cocaine Metabolite Assay (K211973) | Microgenics Corporation | 2021-09-24 |
| Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (K211667) | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 |
| VITROS Chemistry Products PHBR Slides (K210858) | Ortho-Clinical Diagnostics, Inc. | 2021-08-13 |
| AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630) | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 |
| First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup (K210327) | W.H.P.M., Inc. | 2021-08-12 |