PMA P190024S014
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S014
- Product code
- QKF
- Decision date
- 2025-07-31
- Classification
- Pathology
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Approval order statement
- Approval for changes to the concentration of a device component.
Current openFDA PMA Record#
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S014
- Product code
- QKF
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Decision date
- 2025-07-31
- Decision code
- APPR
- Date received
- 2025-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the concentration of a device component.