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510(k) K153596

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control by ARK Diagnostics, Inc. — Product Code POX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2016
Date Received
December 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Oxcarbazepine Metabolite
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.

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