Cleared Traditional

TECO DIAGNOSTICS SALIVA ALCOHOL TEST

K111206 · Teco Diagnostics · Chemistry

Oct 2011

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K111206 is an FDA 510(k) clearance for the TECO DIAGNOSTICS SALIVA ALCOHOL TEST, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on October 4, 2011, 158 days after receiving the submission on April 29, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K111206 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2011
Decision Date	October 04, 2011
Days to Decision	158 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