510(k) K232228 ยท DJG Enzyme Immunoassay, Opiates
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
| Applicant | Shanghai Accurature Diagnostics Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Feb 23, 2024 |
| Received | Jul 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.