510(k) K921176 ยท CEP Radioimmunoassay, Luteinizing Hormone
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Apr 8, 1992 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 Open, Classified |
CEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.