# GFX: Fibrinogen Standard

- Device class: 2; regulation: 21 CFR 864.7340; 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
- 2000: 1
- 2007: 1

## Most-cited predicates
- K994341: Fibrinogen Calibrator Kit (2000), cited by 1

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