# NYQ: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

- Device class: 2; regulation: 21 CFR 864.1890; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 1
- 2019: 2
- 2020: 4
- 2021: 2
- 2022: 6
- 2023: 4
- 2024: 2
- 2025: 3
- 2026: 2

## Most-cited predicates

Source page: https://510kreport.com/product-code/NYQ
Data by year (CSV): https://510kreport.com/product-code/NYQ.csv