Cleared Traditional

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33

K081231 · Abbott Laboratories · Toxicology

Sep 2008

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K081231 is an FDA 510(k) clearance for the ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 26, 2008, 148 days after receiving the submission on May 1, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number	K081231 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2008
Decision Date	September 26, 2008
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF