510(k) K831030 ยท JIX Calibrator, Multi-Analyte Mixture
COBAS STANDARDS FOR GLUCOSE & BUN
| Applicant | Roche Diagnostic Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 9, 1983 |
| Received | Mar 30, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831030
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.