| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K253567) | Healgen Scientific,, LLC | 2025-12-23 |
| Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (K250803) | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| 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 |
| 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 |
| BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| 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 |
| 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 |
| 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 |
| FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) (K240351) | Assure Tech., LLC | 2024-03-06 |
| AllTest Fentanyl Urine Test Cassette (K233417) | Hangzhou AllTest Biotech Co., Ltd. | 2023-10-26 |
| BIOEASY Multi-Drug Test Cup (K193480) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020-01-31 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K190412) | Hangzhou Clongene Biotech Co., Ltd. | 2019-03-21 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K181790) | Hangzhou Clongene Biotech Co., Ltd. | 2018-07-26 |
| AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA (K100108) | Amedica Biotech, Inc. | 2010-04-14 |
| AMEDICA DRUG SCREEN TEST CUP (K082898) | Amedica Biotech, Inc. | 2008-12-19 |