Cleared Traditional

ETOH FLEX REAGENT CARTRIDGE (DF22)

K071811 · Dade Behring, Inc. · Toxicology

Aug 2007

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K071811 is an FDA 510(k) clearance for the ETOH FLEX REAGENT CARTRIDGE (DF22), a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 24, 2007, 52 days after receiving the submission on July 3, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K071811 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2007
Decision Date	August 24, 2007
Days to Decision	52 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