510(k) K082251

SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 by Beckman Coulter, Inc. — Product Code DCF

K082251 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100". The FDA issued a decision of Substantially Equivalent on April 8, 2009. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.