510(k) K974421 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
ELECSYS CK-MB STAT
| Applicant | Boehringer Mannheim Corp., Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Nov 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974421
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.