# GKM: Hand-Tally, Differential

- Device class: 1; regulation: 21 CFR 864.6160; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 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: 1
- 1984: 1
- 1986: 1
- 1988: 1

## Most-cited predicates
- K874188: Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta (1988), cited by 1

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