PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM— 510(k) K100023

Name: FDA 510(k) clearance K100023
Creator: U.S. Food and Drug Administration
Published: 2010-04-05

Substantially Equivalent

Medtox Diagnostics, Inc.

FDA 510(k) clearance K100023 for PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM, Substantially Equivalent on 2010-04-05. Applicant: Medtox Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Medtox Diagnostics, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2010-01-05
Decision date: 2010-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NC, US

Download summary PDF View on FDA.gov ↗

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