510(k) K191245 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Yumizen C1200 ALP, Yumizen C1200 Albumin
| Applicant | HORIBA ABX SAS, Montpellier Cedex 4, FR |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | May 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191245
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.