| K252684 | medtox diagnostics | Labcorp Fentanyl Urine Visual Test | January 29, 2026 |
| K250741 | randox laboratories limited | Evidence MultiSTAT DOA Urine MultiPlex | January 23, 2026 |
| K253082 | lin-zhi international | LZI Buprenorphine II Enzyme Immunoassay | January 16, 2026 |
| K252520 | immunalysis corporation | SEFRIA Hydrocodone Oral Fluid | September 11, 2025 |
| K251972 | healgen scientific | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative | August 15, 2025 |
| K251634 | lin-zhi international | LZI Fentanyl III Enzyme Immunoassay | June 18, 2025 |
| K240124 | vivachek biotech (hangzhou) co | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | June 14, 2024 |
| K240698 | guangzhou decheng biotechnology co | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | May 10, 2024 |
| K231904 | co-innovation biotech co | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | March 8, 2024 |
| K232228 | shanghai accurature diagnostics co | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug | February 23, 2024 |
| K232597 | hangzhou laihe biotech co | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette | January 9, 2024 |
| K232736 | chemtron biotech | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl | December 20, 2023 |
| K232659 | guangzhou decheng biotechnology co | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | December 13, 2023 |
| K231752 | ark diagnostics | ARK Hydrocodone Assay | November 9, 2023 |
| K220451 | randox laboratories limited | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | October 5, 2023 |
| K221550 | randox laboratories limited | Evidence MultiSTAT DOA Urine MultiPlex | October 5, 2023 |
| K231007 | microgenics corporation | CEDIA Heroin Metabolite (6-AM) Assay | September 27, 2023 |
| K231698 | hangzhou alltest biotech co | AllTest Fentanyl Rapid Test (Urine) | July 31, 2023 |
| K221605 | siemens healthcare diagnostics | Emit® II Plus Buprenorphine Assay | July 25, 2023 |
| K230238 | shenzhen bioeasy biotechnology co | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test C | March 31, 2023 |