PMA P140025S004
- Device
- VENTANA ALK (D5F3)
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S004
- Product code
- PKW
- Decision date
- 2017-03-13
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3)
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S004
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2017-03-13
- Decision code
- APPR
- Date received
- 2016-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.