510(k) K803075

DIGOXIN RIABEAD DIAGNOSTIC KIT by Abbott Laboratories — Product Code DON

K803075 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "DIGOXIN RIABEAD DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3320. Abbott Laboratories has at least 10 other 510(k) clearances on record.