510(k) K760416

DATA-TOPE SYSTEM DIGOXIN RIA by Dade, Baxter Travenol Diagnostics, Inc. — Product Code DOG

K760416 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "DATA-TOPE SYSTEM DIGOXIN RIA". The FDA issued a decision of Substantially Equivalent on August 23, 1976. The device falls under product code DOG (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol), a Class II device regulated under 21 CFR 862.3320. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.