510(k) K002551

EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL by Dade Behring, Inc. — Product Code LEG

K002551 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL". The FDA issued a decision of Substantially Equivalent on October 11, 2000. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.