510(k) K090358

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 by Abbott Laboratories, Inc. — Product Code LEG

K090358 is an FDA 510(k) premarket notification submitted by Abbott Laboratories, Inc. for the device "ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35". The FDA issued a decision of Substantially Equivalent on August 6, 2009. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Abbott Laboratories, Inc. has at least 10 other 510(k) clearances on record.