510(k) K042521 ยท JIT Calibrator, Secondary
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Sep 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042521
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.