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510(k) K152232

Quest Diagnostics HairCheck-DT (Cocaine) by Quest Diagnostics Incorporated — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2016
Date Received
August 7, 2015
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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