510(k) K922043 ยท JIX Calibrator, Multi-Analyte Mixture
ROCHE CALIBRATOR SERUM
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 16, 1992 |
| Received | May 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922043
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.