# JZG: System, Test, Beta-2-Microglobulin Immunological

- Device class: 2; regulation: 21 CFR 866.5630; FDA's rule: 510(k) exempt
- FDA decisions: 53
- Recalls: 3 (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)
- 1998: 2
- 1999: 2
- 2000: 2
- 2002: 1
- 2004: 1
- 2005: 1
- 2007: 2
- 2009: 2
- 2012: 2
- 2016: 1

## Most-cited predicates
- K002731: N Latex B2-Microglobulin (2000), cited by 3
- K940353: Beckman Beta-2-Microglobulin (B2M) (1994), cited by 3
- K890421: Imx B2-Microglobulin (1989), cited by 2
- K943686: IL Test Beta-2MICROGLOBULIN (1995), cited by 2
- K991136: B-2-Microglobulin Immunological Test System (1999), cited by 1

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