# GQO: Antisera, Cf, Herpesvirus Hominis 1,2

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1979: 1
- 1985: 6
- 1986: 3
- 1987: 2
- 1988: 2
- 1989: 2

## Most-cited predicates
- K852782: Hsvi - Igg Elisa-Kit (1986), cited by 1
- K852781: HSV2 - Igg Elisa-Kit (1986), cited by 1

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