Cleared Traditional

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM

K091454 · Medtox Diagnostics, Inc. · Toxicology
Jul 2009
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K091454 is an FDA 510(k) clearance for the PROFILE-V MEDTOXSCAN DRUGS OF ABUSE 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 July 24, 2009, 67 days after receiving the submission on May 18, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K091454 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2009
Decision Date July 24, 2009
Days to Decision 67 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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