510(k) K032993 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 31, 2003 |
| Received | Sep 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2021 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427
For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Int Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.