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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, operator intervention
510(k) Number K121033
Device Name VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
Original Applicant
VENTANA MEDICAL SYSTEMS, INC.
575 shirlynn court
los altos,  CA  94022
Original Contact erika ammirati
Regulation Number864.1860
Classification Product Code
NOT  
Subsequent Product Codes
NQN   OEO  
Date Received04/05/2012
Decision Date 09/06/2013
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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