510(k) K050387 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 25, 2005 |
| Received | Feb 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050387
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.