PMA P190024S004
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S004
- Product code
- QKF
- Decision date
- 2021-03-29
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Approval order statement
- Modification of a method for preparing qualified samples used in QC testing.
Current openFDA PMA Record#
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S004
- Product code
- QKF
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Decision date
- 2021-03-29
- Decision code
- OK30
- Date received
- 2021-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of a method for preparing qualified samples used in QC testing.