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510(k) K241428

AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup by Hangzhou AllTest Biotech Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
May 20, 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

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