510(k) K062838 ยท MMI Immunoassay Method, Troponin Subunit
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Dec 19, 2006 |
| Received | Sep 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062838
| 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.