Cleared Traditional

TOXI-LAB CANNABINOID THC SCREEN

K831456 · Marion Laboratories, Inc. · Toxicology
Jun 1983
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K831456 is an FDA 510(k) clearance for the TOXI-LAB CANNABINOID THC SCREEN, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983, 55 days after receiving the submission on May 6, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K831456 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1983
Decision Date June 30, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKE — Reagents, Test, Tetrahydrocannabinol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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