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510(k) K252554

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup by Vivachek Biotech (Hangzhou) Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
August 13, 2025
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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