DJG — Enzyme Immunoassay, Opiates Class II
FDA product code DJG covers "Enzyme Immunoassay, Opiates", a Class II medical device regulated under 21 CFR 862.3650. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DJG
- Device Class
- Class II
- Regulation Number
- 862.3650
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| 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 |
| K221550 | randox laboratories limited | Evidence MultiSTAT DOA Urine MultiPlex | October 5, 2023 |
| K220451 | randox laboratories limited | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | 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 |