# K981476: CHOL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 25, 1998 after 62 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
Longest line of descent: 1 generation back to K896239 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896239: Cobas Ready Cholesterol Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 3.

## Indications for use
The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma. 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/K981476
Methodology: https://510kreport.com/methodology