510(k) K780475

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT by Burroughs Wellcome Co. — Product Code DON

K780475 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 24, 1978. 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.