# P940004: Oncor (R) Amplitect (TM) Her/Neu (ERBB2)Gene Amplifi

- Pathway: PMA
- Applicant: Ventana Medical Systems, Inc.
- Decided: Dec 30, 1997 after 1,415 days
- Product code: MVD (System, Test, Her-2/Neu, Nucleic Acid Or Serum)
- 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/P940004
Methodology: https://510kreport.com/methodology