510(k) K071525

ACTIVATED ASPARTATE AMINOTRANSFERASE by Abbott Laboratories — Product Code CIT

K071525 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ACTIVATED ASPARTATE AMINOTRANSFERASE". The FDA issued a decision of Substantially Equivalent on March 19, 2008. 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.