Cleared Traditional

PROFILE-II MODEL 600582

K982211 · Medtox Diagnostics, Inc. · Toxicology
Jul 1998
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K982211 is an FDA 510(k) clearance for the PROFILE-II MODEL 600582, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 29, 1998, 36 days after receiving the submission on June 23, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K982211 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1998
Decision Date July 29, 1998
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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