PMA P140025S003
- Device
- VENTANA ALK (D5F3) CDX ASSAY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S003
- Product code
- PKW
- Decision date
- 2016-10-21
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for adding the BenchMark ULTRA instrument to the intended use and labeling for the VENTANA ALK (D5F3) CDx Assay
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDX ASSAY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S003
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2016-10-21
- Decision code
- APPR
- Date received
- 2016-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for adding the BenchMark ULTRA instrument to the intended use and labeling for the VENTANA ALK (D5F3) CDx Assay