510(k) K821811

125I DIGOXIN RADIOIMMUNOASSAY KIT by Cambridge Medical Technology — Product Code DPB

K821811 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "125I DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code DPB (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.), a Class II device regulated under 21 CFR 862.3320. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.