510(k) K042494 ยท CZW Complement C3, Antigen, Antiserum, Control
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 19, 2004 |
| Received | Sep 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042494
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.