510(k) K031870

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT by Beckman Coulter, Inc. — Product Code LEG

K031870 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT". The FDA issued a decision of Substantially Equivalent on July 15, 2003. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.