CINtec Histology (50 Tests), CINtec Histology (250 Tests)

Cervical Intraepithelial Neoplasia (cin) Test System

VENTANA MEDICAL SYSTEMS, INC

The following data is part of a De Novo classification by Ventana Medical Systems, Inc with the FDA for Cintec Histology (50 Tests), Cintec Histology (250 Tests).

Pre-market Notification Details

DeNovo IDDEN160019
Device Name:CINtec Histology (50 Tests), CINtec Histology (250 Tests)
ClassificationCervical Intraepithelial Neoplasia (cin) Test System
Applicant VENTANA MEDICAL SYSTEMS, INC 1910 E Innovation Park Dr Tucson,  AZ  85755
ContactRoxane Bonner
Product CodePRB  
CFR Regulation Number864.1865 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardPathology
Classification AdvisoryPathology
TypeDirect
Date Received2016-05-23
Decision Date2017-03-04
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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