510(k) K133330 ยท JIX Calibrator, Multi-Analyte Mixture
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 26, 2013 |
| Received | Nov 1, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133330
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.