PMA P140025S015
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S015
- Product code
- PKW
- Decision date
- 2021-05-20
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S015
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2021-05-20
- Decision code
- APPR
- Date received
- 2021-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.