510(k) K770269

CAMMADISK DIGOXIN by Burroughs Wellcome Co. — Product Code DON

K770269 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "CAMMADISK DIGOXIN". The FDA issued a decision of Substantially Equivalent on March 16, 1977. 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. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.