510(k) K914750 ยท JIX Calibrator, Multi-Analyte Mixture
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Nov 22, 1991 |
| Received | Oct 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914750
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.