# K964660: Paramax Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Jun 4, 1997 after 196 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) DuPont aca Cholesterol Reagent: named in the summary without a submission number

## Indications for use
For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders?.

Source page: https://510kreport.com/device/K964660
Methodology: https://510kreport.com/methodology