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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
510(k) Number K152612
Device Name eSensor Warfarin Sensitivity Saliva Test
Applicant
Genmark Diagnostics, Incorporated
5964 La Place Court,
Carlsbad,  CA  92008
Applicant Contact ALAN MADERAZO
Correspondent
Genmark Diagnostics, Incorporated
5964 La Place Court,
Carlsbad,  CA  92008
Correspondent Contact ALAN MADERAZO
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received09/14/2015
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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