510(k) K100594 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS TROPONIN I CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 1, 2010 |
| Received | Mar 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100594
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.