Cleared Traditional

ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

K080696 · Abbott Laboratories · Toxicology

Sep 2008

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K080696 is an FDA 510(k) clearance for the ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 11, 2008, 183 days after receiving the submission on March 12, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K080696 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2008
Decision Date	September 11, 2008
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF