510(k) K042643

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II by Ortho-Clinical Diagnostics, Inc. — Product Code DCF

K042643 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II". The FDA issued a decision of Substantially Equivalent on November 18, 2004. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.