Cleared Traditional

OPUS ETHANOL

K972011 · Behring Diagnostics, Inc. · Toxicology

Jul 1997

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K972011 is an FDA 510(k) clearance for the OPUS ETHANOL, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 22, 1997, 53 days after receiving the submission on May 30, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K972011 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1997
Decision Date	July 22, 1997
Days to Decision	53 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