510(k) K080607 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Mar 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080607
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.