510(k) K072395

DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS by Diazyme Laboratories — Product Code LBS

K072395 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS". The FDA issued a decision of Substantially Equivalent on January 3, 2008. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Diazyme Laboratories has at least 10 other 510(k) clearances on record.