# JBD: System, Analysis, Electrophoretic Hemoglobin

- Device class: 2; regulation: 21 CFR 864.7440; FDA's rule: 510(k) required
- FDA decisions: 26
- 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)
- 1980: 6
- 1981: 3
- 1982: 1
- 1983: 1
- 1990: 1
- 1993: 2
- 1998: 1
- 1999: 2
- 2004: 1
- 2006: 1

## Most-cited predicates
- K802821: Paragon Hemoglobin Electro. Reag. Kit (1980), cited by 1

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