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510(k) K143187

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) by Healgen Scientific, LLC — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2015
Date Received
November 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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