510(k) K103747

ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS by Elitechgroup Seppim S.A.S. — Product Code LBS

K103747 is an FDA 510(k) premarket notification submitted by Elitechgroup Seppim S.A.S. for the device "ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS". The FDA issued a decision of Substantially Equivalent on August 31, 2011. 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.