# LCS: Radioimmunoassay, Digoxin (125-I)

- Device class: 2; regulation: 21 CFR 862.3320; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1977: 1
- 1980: 6
- 1981: 1
- 1982: 1
- 1987: 1
- 1988: 1
- 1989: 2
- 1991: 1
- 1992: 1

## Most-cited predicates

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