Cleared Traditional

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022

K070853 · Dade Behring, Inc. · Chemistry

Jun 2007

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K070853 is an FDA 510(k) clearance for the DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022, 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 June 13, 2007, 77 days after receiving the submission on March 28, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K070853 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2007
Decision Date	June 13, 2007
Days to Decision	77 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