510(k) K871240

ABBOTT A-GENT LD-1 ISOZYME REAGENT by Abbott Laboratories — Product Code JGF

K871240 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT A-GENT LD-1 ISOZYME REAGENT". The FDA issued a decision of Substantially Equivalent on May 13, 1987. The device falls under product code JGF (Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Abbott Laboratories has at least 10 other 510(k) clearances on record.