PMA P020055S032
- Device
- PATHWAY® Anti-c-KIT (9.7) Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S032
- Product code
- NKF
- Decision date
- 2025-06-20
- Classification
- Pathology
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- qualification of an alternate supplier for assay kit component
Current openFDA PMA Record#
- Device
- PATHWAY® Anti-c-KIT (9.7) Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S032
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2025-06-20
- Decision code
- OK30
- Date received
- 2025-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an alternate supplier for assay kit component