# DGO: Ige, Peroxidase, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1980: 1
- 1982: 1
- 1983: 5
- 1985: 1
- 1986: 1
- 1987: 1
- 1989: 2
- 1991: 1
- 1992: 1
- 1995: 1

## Most-cited predicates
- K911511: Alastat Allergen Specified Ige System, Modified (1991), cited by 3

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