# LBT: Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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
- 1987: 1
- 1988: 1
- 1989: 1
- 1990: 1
- 1997: 1
- 1999: 1
- 2000: 1

## Most-cited predicates
- K000568: HDL Cholesterol Plus (2000), cited by 3

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