510(k) K162275 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Apr 21, 2017 |
| Received | Aug 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162275
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.