# JBL: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

- Device class: 2; regulation: 21 CFR 864.7360; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 1979: 1
- 1999: 1

## Most-cited predicates
- K790211: Dehydrogenose, Glucose Phosphate (1979), cited by 1

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