# KSF: Kit, Quality Control For Blood Banking Reagents

- Device class: 2; regulation: 21 CFR 864.9650; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1977: 2
- 1978: 2
- 1979: 2
- 1980: 4
- 1981: 2

## Most-cited predicates

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