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510(k) K171403

OralTox Oral Fluid Drug Test by Premier Biotech, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2018
Date Received
May 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Premier Biotech, Inc.

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