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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay, Anti-Seizure Drug
510(k) Number K201089
Device Name ARK Lacosamide Assay
Applicant
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Thomas Houts
Correspondent
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Thomas Houts
Regulation Number862.3350
Classification Product Code
NWM  
Date Received04/23/2020
Decision Date 08/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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