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510(k) K253705

Healgen® Accurate Oral Fluid Drug Test by Healgen Scientific,, LLC — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2026
Date Received
November 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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