510(k) K140404 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
ELECSYS CK-MB STAT IMMUNOASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 8, 2014 |
| Received | Feb 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140404
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.