- Device
- PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S004
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2012-11-14
- Decision code
- APPR
- Date received
- 2012-08-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPLEMENTING A CHANGE TO THE VENTANA REGENT DISPENSER SEAL FOR THE BENCHMARK AUTOMATED STAINING INSTRUMENTS.