Cleared Traditional

TOXI*LAB LTD OPIATE SYSTEM

K932209 · Toxi-Lab, Inc. · Toxicology

Sep 1993

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K932209 is an FDA 510(k) clearance for the TOXI*LAB LTD OPIATE SYSTEM, a Thin Layer Chromatography, Opiates (Class II — Special Controls, product code LAI), submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on September 24, 1993, 141 days after receiving the submission on May 6, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number	K932209 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 1993
Decision Date	September 24, 1993
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF