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510(k) K163570

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) by Carolina Liquid Chemistries Corporation — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2017
Date Received
December 19, 2016
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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