MEDTOXSCAN— 510(k) K080635

Substantially Equivalent

Medtox Diagnostics, Inc.

FDA 510(k) clearance K080635 for MEDTOXSCAN, Substantially Equivalent on 2009-02-13. Applicant: Medtox Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Medtox Diagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2008-03-06
Decision date: 2009-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NC, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K080635

K-number listed on FDA's recall record

Z-1329-2013 — PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,Class II·Terminated·Medtox Diagnostics Inc·20130405

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080635.

Data sourced from openFDA. This site is unofficial and independent of the FDA.