510(k) K040280 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 11, 2004 |
| Received | Feb 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040280
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.