| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026-01-23 |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026-01-16 |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025-09-11 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | 2025-08-15 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025-06-18 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024-03-08 |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| K232736 | 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 | Chemtron Biotech, Inc. | 2023-12-20 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023-11-09 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023-10-05 |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023-10-05 |