510(k) K031990 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS PRECICONTROL TROPONIN T
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 20, 2003 |
| Received | Jun 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031990
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.