510(k) K772110

IN VITRO DIGOXIN RIA TEST by Clinical Assays, Inc. — Product Code DNL

K772110 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "IN VITRO DIGOXIN RIA TEST". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.