510(k) K083260 ยท DDR Myoglobin, Antigen, Antiserum, Control
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 16, 2009 |
| Received | Nov 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083260
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.