510(k) K150654 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Cholesterol
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Sep 29, 2015 |
| Received | Mar 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150654
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.