510(k) K250741 ยท DJG Enzyme Immunoassay, Opiates
Evidence MultiSTAT DOA Urine MultiPlex
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Jan 23, 2026 |
| Received | Mar 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250741
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.