Cleared Traditional

ALCOHOL REAGENT SET

K972725 · Pointe Scientific, Inc., · Toxicology

Sep 1997

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K972725 is an FDA 510(k) clearance for the ALCOHOL REAGENT SET, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on September 25, 1997, 66 days after receiving the submission on July 21, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K972725 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1997
Decision Date	September 25, 1997
Days to Decision	66 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