510(k) K771638

IGOXIN SOLID PHASE RIA by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DPO

K771638 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "IGOXIN SOLID PHASE RIA". The FDA issued a decision of Substantially Equivalent on October 7, 1977. The device falls under product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3320. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.