# GIQ: Hemoglobin S

- Device class: 2; regulation: 21 CFR 864.7415; FDA's rule: 510(k) required
- FDA decisions: 3
- 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
- 1995: 1
- 1996: 1

## Most-cited predicates

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