510(k) K162593 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL-Cholesterol Gen.4
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 19, 2016 |
| Received | Sep 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162593
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.