510(k) K143691 ยท LBR Ldl & Vldl Precipitation, Hdl
LDLC3 LDL-Cholesterol Gen.3
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 28, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143691
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.