# K982469: Hichem Cholesterol Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elan Pharma, Inc.
- Decided: Aug 19, 1998 after 35 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 its predicate without a number.
- (no number) Beckman® SYNCHRON® Systems Cholesterol Reagent, product no. 467825: named in the summary without a submission number

## Indications for use
HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This reagent is intended to be used in a professional setting or by trained personnel and is not intended for home use.

Source page: https://510kreport.com/device/K982469
Methodology: https://510kreport.com/methodology