PMA P140025S007
- Device
- Ventana ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S007
- Product code
- PKW
- Decision date
- 2017-08-04
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Current suppliers new manufacturing site for a device component.
Current openFDA PMA Record#
- Device
- Ventana ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S007
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2017-08-04
- Decision code
- OK30
- Date received
- 2017-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Current suppliers new manufacturing site for a device component.