# GKH: Apparatus, Automated Blood Cell Diluting

- Device class: 1; regulation: 21 CFR 864.5240; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 2 (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)
- 1982: 1
- 1984: 2
- 1985: 1
- 1988: 1
- 1990: 1
- 1992: 1
- 1994: 1
- 2002: 2
- 2004: 1
- 2010: 1

## Most-cited predicates
- K040077: Immunicon Celltracks Autoprep System (2004), cited by 1

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