510(k) K961501 ยท JHW U.V. Method, Cpk Isoenzymes
ELECSYS CK-MB
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 11, 1996 |
| Received | Apr 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961501
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.