# GIA: Test, Leukocyte Peroxidase

- Device class: 1; regulation: 21 CFR 864.7675; FDA's rule: 510(k) exempt
- FDA decisions: 3
- 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)
- 1981: 1
- 1985: 1
- 1994: 1

## Most-cited predicates
- K931241: Fast'n'flammatory Kit (1994), cited by 1

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