510(k) K811273

CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CHO

K811273 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code CHO (Radioimmunoassay, Cyclic Amp), a Class II device regulated under 21 CFR 862.1230. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.