# CFL: Radioimmunoassay, Human Growth Hormone

- Device class: 1; regulation: 21 CFR 862.1370; FDA's rule: 510(k) exempt
- FDA decisions: 36
- Recalls: 3 (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: 2
- 1989: 1
- 1990: 2
- 1991: 2
- 1992: 1
- 1993: 1
- 1994: 2
- 1995: 7
- 1996: 5
- 1997: 3

## Most-cited predicates

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