# GHM: Test, Sickle Cell

- Device class: 2; regulation: 21 CFR 864.7825; FDA's rule: 510(k) required
- FDA decisions: 18
- Recalls: 5 (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
- 1983: 1
- 1984: 5
- 1985: 1
- 1986: 2
- 1987: 1
- 1991: 2
- 1996: 1
- 2001: 1
- 2002: 1

## Most-cited predicates
- K013316: Sickle-Chex (2001), cited by 1

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