# JHM: Colorimetric Method, Lipoproteins

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1978: 1
- 1984: 1
- 1990: 1
- 1999: 1
- 2002: 1
- 2003: 1
- 2008: 2
- 2012: 1

## Most-cited predicates
- K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A (2003), cited by 2
- K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B (2008), cited by 1
- K983849: Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge (1999), cited by 1
- K902935: Roche Cobas Ready HDL Cholesterol Reagent (1990), cited by 1

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