510(k) K001679

VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 by Ortho-Clinical Diagnostics, Inc. — Product Code CIT

K001679 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3". The FDA issued a decision of Substantially Equivalent on June 28, 2000. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.