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510(k) K242498

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC by Aicheck Biotech, Inc. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2024
Date Received
August 22, 2024
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

Other clearances by Aicheck Biotech, Inc.

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