# LGR: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

- Device class: 2; regulation: 21 CFR 862.3350; 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)
- 1984: 3
- 1985: 1
- 1986: 1
- 1987: 1
- 1989: 1
- 1990: 1
- 1994: 3
- 1995: 2
- 1996: 2

## Most-cited predicates
- K955562: Innofluor Phenytoin Assay System (1996), cited by 1
- K935375: Axsym Phenytoin Assay (1994), cited by 1
- K936131: Cobas-FP Reagent for Phenytoin and Coba-FP Phenytoin Calibrators (1994), cited by 1

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