Cleared Traditional

RANDOX ETHANOL ASSAY

K092273 · Randox Laboratories, Ltd. · Toxicology

Nov 2010

Decision

461d

Days

Class 2

Risk

About This 510(k) Submission

K092273 is an FDA 510(k) clearance for the RANDOX ETHANOL ASSAY, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 1, 2010, 461 days after receiving the submission on July 28, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K092273 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2009
Decision Date	November 01, 2010
Days to Decision	461 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