510(k) K941615

AXSYM VALPROIC ACID by Abbott Laboratories — Product Code LEG

K941615 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM VALPROIC ACID". The FDA issued a decision of Substantially Equivalent on August 16, 1994. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Abbott Laboratories has at least 10 other 510(k) clearances on record.