Cleared Traditional

MODIFIED LABELING FOR TOXI-LAB THC SCREEN

K875182 · Marion Laboratories, Inc. · Toxicology
Jul 1988
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K875182 is an FDA 510(k) clearance for the MODIFIED LABELING FOR TOXI-LAB THC SCREEN, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on July 5, 1988, 201 days after receiving the submission on December 17, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K875182 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1987
Decision Date July 05, 1988
Days to Decision 201 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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