# GHH: Fibrin Split Products

- Device class: 2; regulation: 21 CFR 864.7320; FDA's rule: 510(k) required
- FDA decisions: 28
- Recalls: 7 (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: 1
- 1997: 1
- 1999: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2007: 2
- 2009: 1
- 2013: 1

## Most-cited predicates
- K030740: Modification to Tina-Quant D-Dimer Test System (2003), cited by 2
- K945642: Agen Dimertest Gold Eia (1995), cited by 2
- K062203: Tina-Quant D-Dimer Test System (2007), cited by 1
- K011143: Tina-Quant D-Dimer Test System (2001), cited by 1

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