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510(k) K170049

AssureTech Panel Dip Test, AssureTech Quick Cup Test by Assure Tech. (Hangzhou) Co, Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2017
Date Received
January 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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