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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name cervical intraepithelial neoplasia (cin) test system
De Novo Number DEN160019
Device Name CINtec Histology (50 tests), CINtec Histology (250 tests)
Requester
ventana medical systems, inc
1910 e innovation park dr
tucson,  AZ  85755
Contact roxane bonner
Regulation Number864.1865
Classification Product Code
PRB  
Date Received05/23/2016
Decision Date 03/04/2017
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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