510(k) K881679

CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code DON

K881679 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 8, 1988. 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. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.