510(k) K171080 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ALP IFCC Gen.2
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, May 10, 2017 |
| Received | Apr 11, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171080
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.