# LBZ: Enzyme Immunoassay, Quinidine

- Device class: 2; regulation: 21 CFR 862.3320; FDA's rule: 510(k) required
- FDA decisions: 27
- 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)
- 1987: 2
- 1989: 1
- 1990: 1
- 1991: 1
- 1992: 1
- 1994: 1
- 1996: 3
- 2001: 1
- 2004: 1
- 2005: 1

## Most-cited predicates
- K941440: Cobas-FP Quinidine Reagents and Calibrators (1994), cited by 1

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