Cleared Traditional

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM

K100023 · Medtox Diagnostics, Inc. · Toxicology
Apr 2010
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K100023 is an FDA 510(k) clearance for the PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 5, 2010, 90 days after receiving the submission on January 5, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K100023 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2010
Decision Date April 05, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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