# GNA: Antisera, All Types, Escherichia Coli

- Device class: 1; regulation: 21 CFR 866.3255; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1988: 1
- 1989: 1
- 1991: 1
- 1994: 1
- 1995: 2
- 1996: 1
- 1998: 1
- 2000: 1
- 2004: 1
- 2007: 1

## Most-cited predicates
- K953362: Premier Ehec (1995), cited by 4

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