VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V

VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V is an FDA 510(k)-cleared medical device (K062094) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Unknown specialty. FDA Device Class U. FDA clearance granted on November 21, 2006.