# JKC: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

- Device class: 1; regulation: 21 CFR 862.1245; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 4 (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)
- 1987: 1
- 1989: 1
- 1990: 1
- 1993: 1
- 1994: 4
- 1995: 1
- 1996: 2
- 1997: 1
- 2001: 1
- 2004: 1

## Most-cited predicates
- K040181: Access Dhea-S Reagent Assay (2004), cited by 1
- K935806: Immulite Dhea-S04 (1994), cited by 1

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