# CHP: Radioimmunoassay, Estradiol

- Device class: 1; regulation: 21 CFR 862.1260; FDA's rule: 510(k) exempt
- FDA decisions: 50
- Recalls: 14 (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)
- 1989: 3
- 1990: 1
- 1991: 5
- 1992: 1
- 1993: 6
- 1994: 2
- 1995: 5
- 1996: 1
- 1997: 6
- 2004: 1

## Most-cited predicates
- K970126: Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545) (1997), cited by 1
- K973743: Access Estradiol Reagents on the Access Immunoassay Analyzer (1997), cited by 1
- K954697: Ciba Corning Acs Estradiol-6 Assay (1995), cited by 1
- K932084: Aia-Pack E2 Assay (1993), cited by 1
- K965109: Elecsys Estradiol Assay (1997), cited by 1
- K932715: Ciba Corning Acs Estradiol Immunoassay (1993), cited by 1

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