510(k) K912807 ยท JFY Enzymatic Method, Creatinine
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Oct 31, 1991 |
| Received | Jun 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912807
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.