# JHJ: Agglutination Method, Human Chorionic Gonadotropin

- Device class: 2; regulation: 21 CFR 862.1155; FDA's rule: 510(k) required
- FDA decisions: 96
- 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)
- 1985: 7
- 1986: 9
- 1987: 1
- 1988: 6
- 1991: 1
- 1992: 1
- 1993: 2
- 1994: 1
- 1996: 1
- 1997: 1

## Most-cited predicates

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