510(k) K980316 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
| Applicant | Diagnostic Chemicals , Ltd., Charlottestown,Pei,Canada, CA |
| Decision | Substantially Equivalent, Feb 12, 1998 |
| Received | Jan 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980316
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.