# GGC: Control, Plasma, Abnormal

- Device class: 2; regulation: 21 CFR 864.5425; FDA's rule: 510(k) exempt
- FDA decisions: 40
- 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)
- 1996: 2
- 1998: 2
- 2000: 1
- 2001: 2
- 2002: 3
- 2003: 1
- 2006: 1
- 2007: 1
- 2010: 1
- 2011: 1

## Most-cited predicates
- K952623: Cryo Check Lupus Plasma (1995), cited by 2
- K003329: Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217 (2001), cited by 2
- K961370: LA Positive Control Plasma (1996), cited by 2
- K020878: Lyphochek Hemostasis, Models 798, 799 (2002), cited by 2
- K952624: Cryo Check Abnormal Reference Check I & II (1995), cited by 1
- K984131: Coagulation Control Level 3 (Abnormal) (1998), cited by 1
- K984130: Coagulation Control Level 2 (Abnormal) (1998), cited by 1
- K924405: Control Plasma P (1992), cited by 1
- K941872: Specialty Assayed Control-2 Cat. NO. 5302 (1994), cited by 1
- K061803: Sta - Control LA 1+2 (2006), cited by 1

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