510(k) K904816

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CDX

K904816 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM". The FDA issued a decision of Substantially Equivalent on January 17, 1991. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.