# GIZ: Plasma, Control, Normal

- Device class: 2; regulation: 21 CFR 864.5425; FDA's rule: 510(k) exempt
- FDA decisions: 20
- Recalls: 1 (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)
- 1993: 1
- 1994: 3
- 1996: 1
- 1997: 1
- 1998: 1
- 2000: 1
- 2001: 2
- 2002: 1
- 2004: 1
- 2007: 1

## Most-cited predicates
- K001256: Control Plasma N (2000), cited by 3
- K042941: Dade Behring Heparin Calibrator and Controls (2004), cited by 2
- K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma (1994), cited by 2
- K023309: Control Plasma N (2002), cited by 2
- K895262: Normal Coagulation Control Plasma (NCCP) (1989), cited by 1
- K984129: Coagulation Control Level 1 (Normal) (1998), cited by 1
- K013708: Reference Check, Catalog Number-RCN-10 (2001), cited by 1
- K905203: Coagulation Reference Plasma, Normal (1990), cited by 1
- K941737: Specialty Assayed Control-1 (1994), cited by 1

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