510(k) K220451 ยท DJG Enzyme Immunoassay, Opiates
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Oct 5, 2023 |
| Received | Feb 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2024 | Randox Laboratories Ltd. Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination
of parent drug molecule and metabolites of drugs in human urine
Catalog Number: EV4115 Open, Classified |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.