# LGQ: Fluorescence Polarization Immunoassay, Phenobarbital

- Device class: 2; regulation: 21 CFR 862.3660; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1984: 1
- 1985: 2
- 1986: 2
- 1987: 1
- 1989: 1
- 1990: 1
- 1994: 2
- 1997: 2

## Most-cited predicates
- K940596: Axsym Phenobarbital (1994), cited by 1
- K936130: Cobas-FP Reagent for Phenobarbital and Cobas-FP Phenobarbital Calibrators (1994), cited by 1

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