# MZO: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

- Device class: 2; regulation: 21 CFR 866.3169; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 208 days (middle half 208–208)
- Recalls: 3 (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)
- 2014: 10
- 2015: 14
- 2016: 19
- 2017: 16
- 2018: 17
- 2019: 11
- 2020: 13
- 2021: 8
- 2023: 1
- 2026: 2

## Most-cited predicates
- P190011: LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab (2019), cited by 2
- P140021: Elecsys Anti-HCV II Immunoassay, Elecsys Precicontrol Anti-HCV (2015), cited by 1

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