PMA P140025S012
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S012
- Product code
- PKW
- Decision date
- 2020-03-31
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for minor software changes.
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S012
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2020-03-31
- Decision code
- APPR
- Date received
- 2020-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software changes.