PMA P140025S024
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S024
- Product code
- PKW
- Decision date
- 2025-03-12
- Classification
- Pathology
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for the migration of the VENTANA ALK (D5F3) Assay from BenchMark ULTRA to BenchMark ULTRA PLUS instrument
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S024
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2025-03-12
- Decision code
- APPR
- Date received
- 2023-12-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the VENTANA ALK (D5F3) Assay from BenchMark ULTRA to BenchMark ULTRA PLUS instrument