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510(k) K252523

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test by Healgen Scientific, LLC — Product Code NFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2026
Date Received
August 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Cannabinoid, Over The Counter
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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