510(k) K062637

VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V by Ortho-Clinical Diagnostics, Inc. — Product Code DJR

K062637 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V". The FDA issued a decision of Substantially Equivalent on November 22, 2006. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.