# CFT: Radioimmunoassay, Prolactin (Lactogen)

- Device class: 1; regulation: 21 CFR 862.1625; FDA's rule: 510(k) exempt
- FDA decisions: 80
- Recalls: 2 (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)
- 1988: 7
- 1989: 4
- 1990: 8
- 1991: 2
- 1992: 5
- 1993: 3
- 1994: 4
- 1995: 4
- 1996: 2
- 1997: 4

## Most-cited predicates
- K896162: Abbott Imx Prolactin (1990), cited by 1
- K964748: Elecsys Prolactin Assay (1997), cited by 1
- K900695: Enzymun Test (R) Prolactin (1990), cited by 1

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