Cleared Traditional

ON.SITE ALCOHOL

K963197 · Ansys, Inc. · Toxicology

Sep 1996

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K963197 is an FDA 510(k) clearance for the ON.SITE ALCOHOL, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Ansys, Inc. (Irvine, US). The FDA issued a Cleared decision on September 19, 1996, 35 days after receiving the submission on August 15, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K963197 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1996
Decision Date	September 19, 1996
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF