510(k) K962549 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
VIDAS CREATINE KINASE MB ASSAY 30-421
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | Jun 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962549
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.