# KRZ: Calibrator For Hemoglobin And Hematocrit Measurement

- Device class: 2; regulation: 21 CFR 864.8165; FDA's rule: 510(k) exempt
- FDA decisions: 25
- 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)
- 1985: 1
- 1986: 1
- 1987: 2
- 1988: 4
- 1989: 1
- 1990: 2
- 1995: 1
- 1996: 1
- 2004: 1
- 2005: 1

## Most-cited predicates
- K052101: C.F.a.S. (Calibrator for Automated Systems) HBA1C (2005), cited by 2
- K840261: Cal-Chex, a Hematology Calibrator (1984), cited by 2

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