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510(k) K080635

MEDTOXSCAN by Medtox Diagnostics, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2009
Date Received
March 6, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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  • K022141 — VERDICT-II (July 30, 2002)
  • K020787 — VERDICT-II PROPOXYPHENE (May 2, 2002)

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