510(k) K060940 ยท JIX Calibrator, Multi-Analyte Mixture
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 24, 2006 |
| Received | Apr 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060940
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.