510(k) K212176
- Device
- CINtec Histology
- Applicant
- Ventana Medical Systems, Inc.
- 510(k) number
- K212176
- Product code
- PRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-10
- Date received
- 2021-07-12
- Regulation
- 864.1865
- Classification name
- Cervical Intraepithelial Neoplasia (cin) Test System
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stacci Cronk
- Address
- 1910 E. Innovation Park Dr. Tucson AZ US 85755 85755
FDA Registration Numbers#
- 2028492
Source Documents#
Other 510(k) Records For Product Code PRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems, Inc. | 2017-03-04 |
Legacy Summary#
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FDA Review#
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