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510(k) K243996

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup by Assure Tech., LLC — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2025
Date Received
December 26, 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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