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510(k) K253567

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card by Healgen Scientific, LLC — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
November 17, 2025
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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