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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 K111872
Device Name VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON,  AZ  85755
Applicant Contact TROY QUANDER
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON,  AZ  85755
Correspondent Contact TROY QUANDER
Regulation Number864.1860
Classification Product Code
NQN  
Subsequent Product Codes
NOT   OEO  
Date Received07/01/2011
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
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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