510(k) K972782 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Dade Intl., Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 15, 1997 |
| Received | Jul 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972782
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.