# GTJ: Antisera, All Groups, N. Meningitidis

- Device class: 2; regulation: 21 CFR 866.3390; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 5 (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)
- 1982: 1
- 1983: 1
- 1984: 2
- 1985: 4
- 1986: 2
- 1987: 1
- 1989: 1
- 1991: 1
- 1992: 1
- 1996: 1

## Most-cited predicates
- K854852: Wellcogen Bacterial Antigen Kit (1986), cited by 2

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