510(k) K133284 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS CK-MB CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Oct 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133284
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.