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510(k) K150356

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
May 13, 2015
Date Received
February 12, 2015
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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  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K123080 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS (November 29, 2012)