510(k) K023058

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM by Seradyn — Product Code KXT

K023058 is an FDA 510(k) premarket notification submitted by Seradyn for the device "QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM". The FDA issued a decision of Substantially Equivalent on October 24, 2002. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Seradyn has at least 10 other 510(k) clearances on record.