510(k) K062094

VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V by Ortho-Clinical Diagnostics, Inc. — Product Code LCM

K062094 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, 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 LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.