510(k) K050026 ยท JIX Calibrator, Multi-Analyte Mixture
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Jan 6, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050026
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.