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510(k) K080347

UNISCAN -DOA SYSTEM by Taiwan Unison Biotech, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2008
Date Received
February 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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