510(k) K981221

ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) by Abbott Laboratories — Product Code CIT

K981221 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)". The FDA issued a decision of Substantially Equivalent on April 23, 1998. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Abbott Laboratories has at least 10 other 510(k) clearances on record.