# NAQ: Lipoprotein, High Density, Hdl, Over The Counter

- Device class: 1; regulation: 21 CFR 862.1175; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (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)
- 2000: 1
- 2006: 1

## Most-cited predicates
- K060617: PTS Panels HDL Cholesterol Test Strips (2006), cited by 3
- K993377: MTM Bioscanner HDL Test Strips, Over the Counter (Otc) (2000), cited by 2

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