510(k) K152344 ยท JFM Enzymatic Method, Bilirubin
Total Bilirubin
| Applicant | Randox Laboratories Limited, Crumlin, County Antrim, GB |
| Decision | Substantially Equivalent, Jan 28, 2016 |
| Received | Aug 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2023 | Randox Laboratories Ltd. RANDOX Total Bilirubin. Open, Classified |
JFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.