# CGJ: Radioimmunoassay, Follicle-Stimulating Hormone

- Device class: 1; regulation: 21 CFR 862.1300; FDA's rule: 510(k) exempt
- FDA decisions: 88
- 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)
- 1992: 4
- 1993: 1
- 1994: 4
- 1995: 1
- 1996: 2
- 1997: 3
- 2001: 1
- 2003: 1
- 2004: 2
- 2005: 2

## Most-cited predicates
- K862813: FSH Maiaclone Immunoradiometric Assay Kit (1986), cited by 1
- K893976: Coat-a-Count (TM) FSH Irma (1989), cited by 1
- K935612: Axsym Follicle Stimulating Hormone (FSH) (1994), cited by 1
- K002450: Genua Menopause Monitor Test Kit (2001), cited by 1
- K900763: Enzymun Test (R) FSH (1990), cited by 1
- K890135: Imx Follicle Stimulating Hormone (FSH) (1989), cited by 1
- K041165: FSH Menopause Predictor Test (2004), cited by 1

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