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510(k) K150096

Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) by Healgen Scientific, LLC — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2015
Date Received
January 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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