# MVJ: Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1999: 3
- 2001: 1
- 2007: 2

## Most-cited predicates
- K071219: Athena Multi-Lyte GBM Test System (2007), cited by 1
- K984336: Quanta Lite GBM Elisa (1999), cited by 1

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