# MGU: Fluorescence Polarization Immunoassay For Cyclosporine

- Device class: 2; regulation: 21 CFR 862.1235; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 1 (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)
- 1989: 1
- 1990: 2
- 1992: 5
- 1994: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2002: 2

## Most-cited predicates
- P890025: TD Cyclosporine and Metabolites Serum Assay (1989), cited by 6

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