510(k) K061249

AXSYM DIGOXIN III by Abbott Laboratories — Product Code KXT

K061249 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM DIGOXIN III". The FDA issued a decision of Substantially Equivalent on June 2, 2006. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Abbott Laboratories has at least 10 other 510(k) clearances on record.