# P140025: Ventana Alk (D5F3) CDX Assay

- Pathway: PMA
- Applicant: Ventana Medical Systems, Inc.
- Decided: Jun 12, 2015 after 210 days
- Product code: PKW (Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P140025
Methodology: https://510kreport.com/methodology