PMA P140025S010
- Device
- Ventana ALK (D5f3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S010
- Product code
- PKW
- Decision date
- 2018-12-07
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Change to purification technology for one of the assay components and improvement in incoming quality control.
Current openFDA PMA Record#
- Device
- Ventana ALK (D5f3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S010
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2018-12-07
- Decision code
- OK30
- Date received
- 2018-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to purification technology for one of the assay components and improvement in incoming quality control.