510(k) K980012 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
CREATINE KINASE REAGENT
| Applicant | Ac Biochemicals, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Jan 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980012
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.