Cleared Traditional

ALCO-SCREEN 02

K121256 · Chematics, Inc. · Toxicology

Sep 2012

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K121256 is an FDA 510(k) clearance for the ALCO-SCREEN 02, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Chematics, Inc. (North Webster, US). The FDA issued a Cleared decision on September 12, 2012, 140 days after receiving the submission on April 25, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K121256 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2012
Decision Date	September 12, 2012
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3040