PMA P140025S011
- Device
- Ventana ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S011
- Product code
- PKW
- Decision date
- 2019-11-19
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.
Current openFDA PMA Record#
- Device
- Ventana ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S011
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2019-11-19
- Decision code
- APPR
- Date received
- 2019-08-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.