# GIL: Plasma, Fibrinogen Control

- Device class: 2; regulation: 21 CFR 864.7340; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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)
- 1983: 1
- 1992: 1
- 1994: 1
- 1995: 4
- 1996: 1

## Most-cited predicates
- K951012: N/T Protein Control PY (1995), cited by 1
- K962407: N/T Protein Control PY (1996), cited by 1

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