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510(k) K101574

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 by ARK Diagnostics, Inc. — Product Code OTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2010
Date Received
June 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gabapentin Assay
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

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