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510(k) K201089

ARK Lacosamide Assay by ARK Diagnostics, Inc. — Product Code NWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2021
Date Received
April 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay, Anti-Seizure Drug
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

To aid in management of patients treated with anti-seizure drug.

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Other clearances for product code NWM

  • K091884 — ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODE (December 9, 2009)
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  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)