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510(k) K261280

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2026
Date Received
April 17, 2026
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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