PMA P140025S005
- Device
- VENTANA ALK (D5F3) CDX ASSAY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S005
- Product code
- PKW
- Decision date
- 2017-05-26
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for extending the label claim of the VENTANA ALK (D5F3) CDx Assay to include an indication for Zykadia (ceritinib)
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDX ASSAY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S005
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2017-05-26
- Decision code
- APPR
- Date received
- 2016-12-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the label claim of the VENTANA ALK (D5F3) CDx Assay to include an indication for Zykadia (ceritinib)