510(k) K062165

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS by Ortho-Clinical Diagnostics — Product Code DIS

K062165 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.