510(k) K033300 ยท DDR Myoglobin, Antigen, Antiserum, Control
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 5, 2003 |
| Received | Oct 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2018 | Ortho Clinical Diagnostics Inc Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Sy Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.