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510(k) K163704

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card by Healgen Scientific, LLC — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2017
Date Received
December 29, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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