# GHR: Reagent, Platelet Aggregation

- Device class: 2; regulation: 21 CFR 864.5700; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 1976: 1
- 1982: 1
- 1983: 1
- 1990: 1
- 1991: 4
- 1992: 1
- 1995: 1
- 2007: 1

## Most-cited predicates
- K760198: Kit, Platelet Aggregation Reagent (#390) (1976), cited by 2

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