# JBF: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

- Device class: 2; regulation: 21 CFR 864.7360; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 876 days (middle half 876–876)
- 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)
- 1995: 1
- 2003: 1
- 2008: 1
- 2016: 1
- 2022: 1

## Most-cited predicates
- K024006: G6PDH, Glucose-6-Phoshate Dehydrogenase (2003), cited by 1
- K933934: Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-a (1995), cited by 1
- K080003: Binaxnow G6PD Test (2008), cited by 1

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