The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Cintec Histology.
| Device ID | K212176 |
| 510k Number | K212176 |
| Device Name: | CINtec Histology |
| Classification | Cervical Intraepithelial Neoplasia (cin) Test System |
| Applicant | Ventana Medical Systems, Inc. 1910 E Innovation Park Drive Tucson, AZ 85755 |
| Contact | Stacci Cronk |
| Correspondent | Stacci Cronk Ventana Medical Systems, Inc. 1910 E Innovation Park Drive Tucson, AZ 85755 |
| Product Code | PRB |
| CFR Regulation Number | 864.1865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2021-12-10 |