510(k) K022654 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 29, 2002 |
| Received | Aug 9, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022654
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.