Cleared Traditional

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY

K952839 · Boehringer Mannheim Corp. · Toxicology

Aug 1995

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K952839 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on August 24, 1995, 64 days after receiving the submission on June 21, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K952839 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 1995
Decision Date	August 24, 1995
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF