# CJM: Radioimmunoassay, Aldosterone

- Device class: 2; regulation: 21 CFR 862.1045; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1980: 1
- 1983: 1
- 1984: 1
- 1986: 1
- 1992: 1
- 1995: 1
- 2003: 1
- 2005: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K831178: Coat-a-Count NO-Extraction Aldosterone (1983), cited by 3
- K800775: Aldoctk-125 (1980), cited by 1

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