510(k) K051962

ULTRA HDL by Abbott Laboratories — Product Code LBS

K051962 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ULTRA HDL". The FDA issued a decision of Substantially Equivalent on August 25, 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. Abbott Laboratories has at least 10 other 510(k) clearances on record.