# GGK: Products, Red-Cell Lysing Products

- Device class: 1; regulation: 21 CFR 864.8540; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 6 (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)
- 1979: 2
- 1980: 1
- 1981: 1
- 1982: 3
- 1983: 3
- 1984: 8
- 1985: 2
- 1986: 2
- 1987: 2
- 1988: 2

## Most-cited predicates

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