510(k) K032035

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI by Beckman Coulter, Inc. — Product Code CZW

K032035 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI". The FDA issued a decision of Substantially Equivalent on August 7, 2003. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.