# K972853: Cholesterol Rapid Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Reagents Applications, Inc.
- Decided: Sep 24, 1997 after 89 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

Source page: https://510kreport.com/device/K972853
Methodology: https://510kreport.com/methodology