# GGN: Plasma, Coagulation Control

- Device class: 2; regulation: 21 CFR 864.5425; FDA's rule: 510(k) exempt
- FDA decisions: 99
- Recalls: 11 (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)
- 2007: 3
- 2008: 1
- 2009: 2
- 2010: 3
- 2011: 2
- 2012: 1
- 2013: 3
- 2014: 2
- 2016: 2
- 2017: 4

## Most-cited predicates
- K955278: Behring Coagulation Timer (1996), cited by 7
- K771346: CI-Trol Coagulation Controls II & Iii (1977), cited by 4
- K030965: Control Plasma LMW Heparin (2003), cited by 3
- K952622: Cryo Check Normal Human Reference Plasma (1995), cited by 2
- K021024: Hemosil High Abnormal Control Assayed (2002), cited by 2
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (2016), cited by 2
- K010350: Sta -Calibrator HBPM/LMWH Kit (2001), cited by 2
- K021023: Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) (2002), cited by 2
- K042206: Purple/Black Heparin Assay Control (2004), cited by 1
- K042175: Heparinase HR Act Control, Model 550-12 (2004), cited by 1

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