# P020055: Ventana Medical Systems Pathway Anti-C-Kit (9.7) Primary Antibody

- Pathway: PMA
- Applicant: Ventana Medical Systems, Inc.
- Decided: Aug 11, 2004 after 596 days
- Product code: NKF (Immunohistochemistry Antibody Assay, C-Kit)
- Device class: 3
- Regulation: 21 CFR 864.1860
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- May 16, 2011 · Not classified · Z-2717-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K
- May 16, 2011 · Not classified · Z-2716-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K

Source page: https://510kreport.com/device/P020055
Methodology: https://510kreport.com/methodology