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510(k) K181499

DRI Cocaine Metabolite Assay by Microgenics Corporation — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
June 7, 2018
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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