# GGL: Control, White-Cell

- Device class: 2; regulation: 21 CFR 864.8625; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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)
- 1989: 2
- 1992: 1
- 1994: 1
- 1996: 1
- 1999: 1
- 2005: 1
- 2009: 1

## Most-cited predicates
- K920997: CD-Chex (1992), cited by 2
- K960894: CD-Chex + RBC (1996), cited by 2
- K894651: Coulter Positive Control Cells (1989), cited by 1
- K051633: CD-Chex Plus BC (2005), cited by 1

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