510(k) K973030 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 4, 1997 |
| Received | Aug 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2013 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic System Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.