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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 K083799
Device Name TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
Applicant
Ark Diagnostics, Inc.
1190 Bordeaux Dr.
Sunnyvale,  CA  94089
Applicant Contact JOHNNY VALDEZ
Correspondent
Ark Diagnostics, Inc.
1190 Bordeaux Dr.
Sunnyvale,  CA  94089
Correspondent Contact JOHNNY VALDEZ
Regulation Number862.3350
Classification Product Code
NWM  
Subsequent Product Codes
DLJ   LAS  
Date Received12/22/2008
Decision Date 04/16/2009
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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