510(k) K002285 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ATAC PAK ALP REAGENT KIT
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Sep 26, 2000 |
| Received | Jul 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002285
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.