510(k) K033873 ยท JIX Calibrator, Multi-Analyte Mixture
ELECSYS C-PEPTIDE CALSET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033873
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.