# JHO: Electrophoretic Separation, Lipoproteins

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 26
- 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)
- 1988: 1
- 1989: 1
- 1994: 2
- 1996: 3
- 1997: 1
- 1998: 3
- 1999: 1
- 2000: 1
- 2001: 2
- 2002: 4

## Most-cited predicates
- K833611: Titan Gel Lipoprotein Electrophoresis (1984), cited by 2
- K854057: Paragon Electrophoresis Sys Lipoprotein Reagent TE (1985), cited by 1
- K935162: Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit (1994), cited by 1

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