510(k) K760709

EMIT DIGOKIN ASSAY by Syva Co. — Product Code DOG

K760709 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT DIGOKIN ASSAY". The FDA issued a decision of Substantially Equivalent on October 21, 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. Syva Co. has at least 10 other 510(k) clearances on record.