Cleared Traditional

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

K081938 · Genzyme Diagnostics P.E.I., Inc. · Toxicology

May 2009

Decision

297d

Days

Class 2

Risk

About This 510(k) Submission

K081938 is an FDA 510(k) clearance for the ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Genzyme Diagnostics P.E.I., Inc. (Charlottetown, Prin Ed Island, CA). The FDA issued a Cleared decision on May 1, 2009, 297 days after receiving the submission on July 8, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number	K081938 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2008
Decision Date	May 01, 2009
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF