Cleared Traditional

ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

K001286 · Diagnostic Chemicals , Ltd. · Toxicology

Jun 2000

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K001286 is an FDA 510(k) clearance for the ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on June 20, 2000, 60 days after receiving the submission on April 21, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K001286 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2000
Decision Date	June 20, 2000
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

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