510(k) K897097 ยท JIX Calibrator, Multi-Analyte Mixture
COBAS READY CALIBRATOR KIT
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Jun 26, 1990 |
| Received | Dec 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897097
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.