510(k) K850396 ยท JIX Calibrator, Multi-Analyte Mixture
ROCHE STANDARDS FOR CHLORIDE & CO2
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Feb 27, 1985 |
| Received | Feb 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850396
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.