510(k) K080696

ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 by Abbott Laboratories — Product Code DIP

K080696 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01". The FDA issued a decision of Substantially Equivalent on September 11, 2008. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Abbott Laboratories has at least 10 other 510(k) clearances on record.