510(k) K053157

AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A by Dade Behring, Inc. — Product Code LBS

K053157 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A". The FDA issued a decision of Substantially Equivalent on December 9, 2005. 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. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.