510(k) K842713

TDX DISOPYRAMIDE by Abbott Laboratories — Product Code LBZ

K842713 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX DISOPYRAMIDE". The FDA issued a decision of Substantially Equivalent on August 29, 1984. The device falls under product code LBZ (Enzyme Immunoassay, Quinidine), a Class II device regulated under 21 CFR 862.3320. Abbott Laboratories has at least 10 other 510(k) clearances on record.