# JBE: Cell Enzymes (Erythrocytic And Leukocytic)

- Device class: 2; regulation: 21 CFR 864.7100; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 1982: 1

## Most-cited predicates
- K822733: Sigma Reagent System NO. 885 (1982), cited by 1

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