510(k) K081231

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 by Abbott Laboratories — Product Code DLZ

K081231 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33". The FDA issued a decision of Substantially Equivalent on September 26, 2008. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Abbott Laboratories has at least 10 other 510(k) clearances on record.