PMA P190024S015
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S015
- Product code
- QKF
- Decision date
- 2025-09-04
- Classification
- Pathology
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Approval order statement
- approval for the addition of two new suppliers for two different raw materials
Current openFDA PMA Record#
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S015
- Product code
- QKF
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Decision date
- 2025-09-04
- Decision code
- OK30
- Date received
- 2025-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of two new suppliers for two different raw materials