510(k) K052819

VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III by Ortho-Clinical Diagnostics, Inc. — Product Code DEM

K052819 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III". The FDA issued a decision of Substantially Equivalent on December 23, 2005. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.