510(k) K153435 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Direct HDL Cholesterol (HDL)
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jan 8, 2016 |
| Received | Nov 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153435
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.