Cleared Traditional

ALCO-SCREEN

K121247 · Chematics, Inc. · Chemistry

Mar 2013

Decision

331d

Days

Class 2

Risk

About This 510(k) Submission

K121247 is an FDA 510(k) clearance for the ALCO-SCREEN, 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 March 22, 2013, 331 days after receiving the submission on April 25, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K121247 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2012
Decision Date	March 22, 2013
Days to Decision	331 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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