510(k) K072395 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Jan 3, 2008 |
| Received | Aug 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072395
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.