CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Roche Diagnostics Hitachi 917  {ARK Diagnostics Topiramate Assay}  Document Number K083799 Analyte Name Topiramate Analyte Specialty Toxicology / TDM Complexity MODERATE Effective Date 04/30/2009 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 drive sunnyvale,  CA  94089 Contact johnny valdez Regulation Number 862.3350 Classification Product Code NWM   Subsequent Product Codes DLJ   LAS   Date Received 12/22/2008 Decision Date 04/16/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Toxicology Review Advisory Committee Toxicology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No