510(k) K040245 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 24, 2004 |
| Received | Feb 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040245
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.