510(k) K973331 ยท DBF Ferritin, Antigen, Antiserum, Control
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 22, 1997 |
| Received | Sep 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973331
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.