510(k) DEN160019
- Device
- CINtec Histology (50 tests), CINtec Histology (250 tests)
- Applicant
- Ventana Medical Systems, Inc.
- 510(k) number
- DEN160019
- Product code
- PRB
- Decision
- Unknown (DENG)
- Decision date
- 2017-03-04
- Date received
- 2016-05-23
- Regulation
- 864.1865
- Classification name
- Cervical Intraepithelial Neoplasia (Cin) Test System
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROXANE BONNER
- Address
- 1910 E. Innovation Park Dr. Tucson AZ US 85755 85755
FDA Registration Numbers#
- 2028492
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PRB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | 2021-12-10 |