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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number K110786
Model ESENSOR XT-8
Device Name ESENSOR WARFARIN SENSITIVITY SALIVA TEST
Original Applicant
GENMARK DIAGNOSTICS, INC
5964 la place court
suite 100
carlsbad,  CA  92008
Original Contact john riolo
Regulation Number862.2570
Classification Product Code
NSU  
Subsequent Product Codes
ODV   ODW  
Date Received03/29/2011
Decision Date 12/02/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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