510(k) K895569

VALPROIC ACID (FPIA) KIT by Tudor Laboratories, Inc. — Product Code LEG

K895569 is an FDA 510(k) premarket notification submitted by Tudor Laboratories, Inc. for the device "VALPROIC ACID (FPIA) KIT". The FDA issued a decision of Substantially Equivalent on October 3, 1989. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Tudor Laboratories, Inc. has at least 8 other 510(k) clearances on record.