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).
| DeNovo ID | DEN160019 |
| Device Name: | CINtec Histology (50 Tests), CINtec Histology (250 Tests) |
| Classification | Cervical Intraepithelial Neoplasia (cin) Test System |
| Applicant | VENTANA MEDICAL SYSTEMS, INC 1910 E Innovation Park Dr Tucson, AZ 85755 |
| Contact | Roxane Bonner |
| Product Code | PRB |
| CFR Regulation Number | 864.1865 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Pathology |
| Classification Advisory | Pathology |
| Type | Direct |
| Date Received | 2016-05-23 |
| Decision Date | 2017-03-04 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |