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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 K050012
Device Name VENTANA IMAGE ANALYSIS SYSTEM
Applicant
TRIPATH IMAGING, INC.
780 PLANTATION DR.
BURLINGTON,  NC  27215
Applicant Contact BRYAN TUCKER
Correspondent
TRIPATH IMAGING, INC.
780 PLANTATION DR.
BURLINGTON,  NC  27215
Correspondent Contact BRYAN TUCKER
Regulation Number864.1860
Classification Product Code
NQN  
Date Received01/03/2005
Decision Date 05/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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