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510(k) K234006

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test by Allsource Screening Solutions — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
December 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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