PMA P190024S013
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S013
- Product code
- QKF
- Decision date
- 2025-04-25
- Classification
- Pathology
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Approval order statement
- Approval for migration of the CINtec PLUS Cytology assay to a new automated slide stainer instrument, BenchMark ULTRA PLUS.
Current openFDA PMA Record#
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S013
- Product code
- QKF
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Decision date
- 2025-04-25
- Decision code
- APPR
- Date received
- 2024-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for migration of the CINtec PLUS Cytology assay to a new automated slide stainer instrument, BenchMark ULTRA PLUS.