# MOJ: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

- Device class: 2; regulation: 21 CFR 862.3350; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 69 days (middle half 69–69)
- 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)
- 1995: 2
- 2023: 1

## Most-cited predicates
- K952555: Cobas-FP Application for Free Phenytoin, Cobas-FP Phenytoin Calibrators, & Controls (1995), cited by 1

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