510(k) K042476

VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS by Ortho-Clinical Diagnostics, Inc. — Product Code LEG

K042476 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.