# GGM: Control, Hemoglobin

- Device class: 2; regulation: 21 CFR 864.8625; FDA's rule: 510(k) exempt
- FDA decisions: 15
- 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)
- 1985: 1
- 1989: 1
- 1992: 1
- 1996: 2
- 1999: 1
- 2000: 1
- 2003: 1
- 2005: 1
- 2007: 2
- 2019: 2

## Most-cited predicates
- K964052: Hemocue Hemotrol (1996), cited by 1
- K993321: R&D HGB/GLC Whole Blood Control (1999), cited by 1
- K182744: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (2019), cited by 1
- K032791: Glycohemosure HBA1C Control (2003), cited by 1
- K003030: Lyphochek Hemoglobin Alc Linearity Set (2000), cited by 1
- K052838: Liquichek Diabetes Control, Level 1,2,3,4 (2005), cited by 1

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