510(k) K100010 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL CHOLESTEROL (HDLX) ASSAY
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 14, 2010 |
| Received | Jan 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100010
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.