# LQN: Latex Agglutination Assay, Rubella

- Device class: 2; regulation: 21 CFR 866.3510; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1985: 2
- 1986: 2
- 1989: 2
- 1990: 1
- 1992: 1
- 1996: 3
- 1997: 1
- 2003: 1

## Most-cited predicates

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