# K120202: Eon Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Vital Diagnostics Pty., Ltd.
- Decided: Jul 27, 2012 after 186 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K120202
Methodology: https://510kreport.com/methodology