# CGI: Radioimmunoassay, Estriol

- Device class: 1; regulation: 21 CFR 862.1265; FDA's rule: 510(k) exempt
- FDA decisions: 42
- 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)
- 1982: 6
- 1983: 1
- 1984: 3
- 1985: 3
- 1986: 1
- 1990: 1
- 1992: 1
- 1994: 2
- 1996: 2
- 1998: 1

## Most-cited predicates

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