| K253567 | healgen scientific | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te | December 23, 2025 |
| K250803 | anhui deepblue medical technological co | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | April 15, 2025 |
| K250067 | guangzhou decheng biotechnology co | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | February 20, 2025 |
| K242428 | guangzhou decheng biotechnology co | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche | February 6, 2025 |
| K243365 | healgen scientific | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru | December 17, 2024 |
| K243064 | eterbio | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfe | November 20, 2024 |
| K242802 | hangzhou clongene biotech co | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | November 8, 2024 |
| K241869 | vivachek biotech (hangzhou) co | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSi | October 4, 2024 |
| K241969 | qingdao hightop biotech co | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl | August 14, 2024 |
| K241741 | guangzhou wondfo biotech co | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Te | July 16, 2024 |
| K241100 | co-innovation biotech co | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | May 22, 2024 |
| K240949 | healgen scientific | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid | May 13, 2024 |
| K240686 | healgen scientific | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te | April 12, 2024 |
| K240654 | safecare biotech (hangzhou) co | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | April 10, 2024 |
| K240295 | instanosis | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine | March 28, 2024 |
| K234006 | allsource screening solutions | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | March 21, 2024 |
| K240351 | assure tech | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Uri | March 6, 2024 |
| K233417 | hangzhou alltest biotech co | AllTest Fentanyl Urine Test Cassette | October 26, 2023 |
| K193480 | shenzhen bioeasy biotechnology co | BIOEASY Multi-Drug Test Cup | January 31, 2020 |
| K190412 | hangzhou clongene biotech co | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | March 21, 2019 |