510(k) K014103

SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR by Beckman Coulter, Inc. — Product Code MRR

K014103 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 28, 2002. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.