510(k) K830206

TDX N-ACETYLPROCAINAMIDE by Abbott Laboratories — Product Code LAN

K830206 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX N-ACETYLPROCAINAMIDE". The FDA issued a decision of Substantially Equivalent on February 18, 1983. 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.