# KQJ: System, Fibrinogen Determination

- Device class: 2; regulation: 21 CFR 864.7340; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 28 days (middle half 28–28)
- 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)
- 1988: 1
- 1989: 1
- 1990: 2
- 1992: 2
- 1993: 3
- 1994: 1
- 1997: 3
- 2005: 1
- 2007: 1
- 2025: 1

## Most-cited predicates
- K073367: Hemosil Fibrinogen-C (2007), cited by 1
- K925988: Multifibren (1993), cited by 1
- K800826: Fibrinogen Screen (1980), cited by 1
- K934326: Multifibren U (1994), cited by 1
- K931721: IL Test Fibrinogen-C (1993), cited by 1

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