510(k) K884550 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 23, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884550
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.