510(k) K772422

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA by Bio-Rad — Product Code DON

K772422 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA". The FDA issued a decision of Substantially Equivalent on February 13, 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. Bio-Rad has at least 10 other 510(k) clearances on record.