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510(k) K242077

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup by Aicheck Biotech, Inc. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
July 16, 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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