510(k) K101365 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS CA 19-9 CALCHECK 5
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 5, 2010 |
| Received | May 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101365
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.