510(k) K895250 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Oct 31, 1989 |
| Received | Aug 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895250
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.