510(k) K844167

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DKP

K844167 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code DKP (Radioimmunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.