PMA P020055S022
- Device
- PATHWAY Anti-c-KIT (9.7) Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S022
- Product code
- NKF
- Decision date
- 2020-03-31
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- Approval for minor software changes.
Current openFDA PMA Record#
- Device
- PATHWAY Anti-c-KIT (9.7) Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S022
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2020-03-31
- Decision code
- APPR
- Date received
- 2020-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software changes.