PMA P020055S019
- Device
- PATHWAY ANTI-C-KIT
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S019
- Product code
- NKF
- Decision date
- 2017-03-13
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.
Current openFDA PMA Record#
- Device
- PATHWAY ANTI-C-KIT
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S019
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2017-03-13
- Decision code
- APPR
- Date received
- 2016-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.