Cleared Traditional

PARAMAX ALCOHOL REAGENT

K934275 · Baxter Diagnostics, Inc. · Toxicology

Apr 1994

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K934275 is an FDA 510(k) clearance for the PARAMAX ALCOHOL REAGENT, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Baxter Diagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 26, 1994, 238 days after receiving the submission on August 31, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K934275 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1993
Decision Date	April 26, 1994
Days to Decision	238 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