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510(k) K141647

HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) by Healgen Scientific, LLC — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2014
Date Received
June 19, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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