# P990081: Pathway Anti-HCR-2/Ncu (4B5) Rabbit Monoclonal Primary Antibody

- Pathway: PMA
- Applicant: Ventana Medical Systems, Inc.
- Decided: Nov 28, 2000 after 351 days
- Product code: MVC (System, Test, Her-2/Neu, Ihc)
- Device class: 3
- Recalls of this device: 3 (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
- Sep 17, 2009 · Not classified · Z-1146-2010: Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.

Source page: https://510kreport.com/device/P990081
Methodology: https://510kreport.com/methodology