510(k) K031031 ยท MMI Immunoassay Method, Troponin Subunit
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 29, 2003 |
| Received | Apr 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2007 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK Terminated |
MMI | None listed |
| Jul 20, 2004 | Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Orth Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.