510(k) K152343 ยท JFM Enzymatic Method, Bilirubin
Direct Bilirubin
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Feb 16, 2016 |
| Received | Aug 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152343
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.