| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 | 88 | 0 |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test | Assure Tech., LLC | 2026-07-17 | 35 | 0 |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Uri | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 | 35 | 0 |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip M | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 | 109 | 0 |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026-03-16 | 112 | 0 |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cu | WEBEST Biotech,, LLC | 2026-03-09 | 34 | 0 |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Acc | Healgen Scientific,, LLC | 2026-02-12 | 185 | 0 |
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 | 157 | 0 |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026-01-23 | 318 | 0 |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026-01-16 | 115 | 0 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurat | Healgen Scientific,, LLC | 2025-12-23 | 36 | 0 |
| K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | 2025-11-26 | 180 | 0 |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Mul | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 | 97 | 0 |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Tes | Advin Biotech, Inc. | 2025-10-09 | 30 | 0 |
| K250609 | Sober Self-Test | Sober Ip, LLC | 2025-09-15 | 199 | 0 |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 | 30 | 0 |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | 2025-09-11 | 265 | 0 |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025-09-11 | 31 | 0 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 | 51 | 0 |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test | Assure Tech., LLC | 2025-08-15 | 25 | 0 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Te | Healgen Scientific,, LLC | 2025-08-15 | 50 | 0 |
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | 2025-08-01 | 266 | 0 |
| K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025-07-09 | 239 | 0 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025-06-18 | 20 | 0 |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 | 29 | 0 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 | 24 | 0 |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 | 411 | 0 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 | 59 | 0 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 | 41 | 0 |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; Assu | Assure Tech., LLC | 2025-02-07 | 43 | 0 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Te | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 | 175 | 0 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Ac | Healgen Scientific,, LLC | 2024-12-17 | 49 | 0 |
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | 2024-12-11 | 29 | 0 |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ET | Eterbio, Inc. | 2024-11-20 | 54 | 0 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 | 52 | 0 |
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | 2024-10-30 | 233 | 0 |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 | 99 | 0 |
| K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Pan | Aicheck Biotech, Inc. | 2024-10-01 | 40 | 0 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapi | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 | 32 | 0 |
| K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Te | Aicheck Biotech, Inc. | 2024-08-14 | 29 | 0 |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Pane | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 | 40 | 0 |
| K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fen | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 | 29 | 0 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 | 28 | 0 |
| K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Rea | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 | 150 | 0 |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl | Co-Innovation Biotech Co., Ltd. | 2024-05-22 | 30 | 0 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Heal | Healgen Scientific,, LLC | 2024-05-13 | 35 | 0 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 | 57 | 0 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurat | Healgen Scientific,, LLC | 2024-04-12 | 31 | 0 |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Te | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-04-10 | 34 | 0 |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl | Instanosis, Inc. | 2024-03-28 | 56 | 0 |