510(k) K071580

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL by Thermofisher Scientific OY — Product Code CIT

K071580 is an FDA 510(k) premarket notification submitted by Thermofisher Scientific OY for the device "AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Thermofisher Scientific OY has at least 7 other 510(k) clearances on record.