Cleared Traditional

ON-SITE ALCOHOL

K903223 · Toxi-Lab, Inc. · Toxicology

Mar 1991

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K903223 is an FDA 510(k) clearance for the ON-SITE ALCOHOL, a Potassium Dichromate, Alcohol (Class II — Special Controls, product code DOJ), submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on March 13, 1991, 233 days after receiving the submission on July 23, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K903223 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1990
Decision Date	March 13, 1991
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—