# CFP: Radioimmunoassay, Immunoreactive Insulin

- Device class: 1; regulation: 21 CFR 862.1405; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 6 (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)
- 1981: 4
- 1982: 3
- 1983: 1
- 1984: 1
- 1985: 1
- 1989: 1
- 1990: 3
- 1992: 2
- 1995: 1
- 1996: 1

## Most-cited predicates
- K903628: Aia-Pack Iri (1990), cited by 1

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