510(k) K992366 ยท MMI Immunoassay Method, Troponin Subunit
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 8, 1999 |
| Received | Jul 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2023 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Open, Classified |
MMI | None listed |
| Aug 8, 2023 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Troponin I ES Calibrators Open, Classified |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.