510(k) K062737

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER by Horiba Abx — Product Code CGS

K062737 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 12, 2007. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Horiba Abx has at least 10 other 510(k) clearances on record.