510(k) K050632 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, May 26, 2005 |
| Received | Mar 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050632
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.