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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity
510(k) Number K121516
Device Name VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
Original Applicant
VENTANA MEDICAL SYSTEMS, INC.
575 shirlynn court
los altos,  CA  94022
Original Contact erika ammirati
Regulation Number864.1860
Classification Product Code
NQN  
Subsequent Product Codes
NOT   OEO  
Date Received05/22/2012
Decision Date 09/26/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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