510(k) K000576 ยท JIX Calibrator, Multi-Analyte Mixture
ELECSYS CORTISOL CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 21, 2000 |
| Received | Feb 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000576
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.