510(k) K132571 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 18, 2013 |
| Received | Aug 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132571
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.