# OBF: Assay, Genotyping, Hepatitis C Virus

- Device class: 2; regulation: 21 CFR 866.3170; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 0 (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)
- 2013: 4
- 2014: 3
- 2015: 2
- 2016: 6
- 2017: 2
- 2018: 2
- 2019: 3
- 2020: 2
- 2021: 1

## Most-cited predicates

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