510(k) K161691 ยท MRR System, Test, Low Density, Lipoprotein
Direct LDL Cholesterol (LDL)
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Mar 20, 2017 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161691
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.