510(k) K130141 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 22, 2013 |
| Received | Jan 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130141
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.