510(k) K011658 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
| Applicant | Rochdiag, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 31, 2001 |
| Received | May 29, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K011658
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.