PMA P020055S020
- Device
- Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S020
- Product code
- NKF
- Decision date
- 2017-08-04
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- Current suppliers new manufacturing site for a device component.
Current openFDA PMA Record#
- Device
- Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S020
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2017-08-04
- Decision code
- OK30
- Date received
- 2017-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Current suppliers new manufacturing site for a device component.