# JHR: Radioimmunoassay, Immunoglobulins (D, E)

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1984: 1
- 1987: 1
- 1988: 1
- 1990: 2
- 1993: 1
- 1996: 1
- 1999: 1
- 2006: 1

## Most-cited predicates
- K984326: Elecys Ige Assay (1999), cited by 1
- K061970: Elecsys Ige II Immunoassay (2006), cited by 1

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