510(k) K913921 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Nov 22, 1991 |
| Received | Sep 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913921
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.