510(k) K100550 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Sep 28, 2010 |
| Received | Feb 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100550
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.