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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 K061613
Device Name VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
Applicant
Tripath Imaging
4025 Stirrup Creek Dr., Suite 400
Durham,  NC  27703
Applicant Contact BRYAN J TUCKER
Correspondent
Tripath Imaging
4025 Stirrup Creek Dr., Suite 400
Durham,  NC  27703
Correspondent Contact BRYAN J TUCKER
Regulation Number864.1860
Classification Product Code
NQN  
Date Received06/09/2006
Decision Date 01/10/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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