510(k) K955422

AXSYM N-ACETYLPROCAINAMIDE by Abbott Laboratories — Product Code LAN

K955422 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM N-ACETYLPROCAINAMIDE". The FDA issued a decision of Substantially Equivalent on April 24, 1996. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. Abbott Laboratories has at least 10 other 510(k) clearances on record.