# K973988: Rdi Homogeneous HDL Cholesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Reference Diagnostics, Inc.
- Decided: Dec 22, 1997 after 62 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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
For use in clinical laboratories and physicians’ office laboratories for quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease.

Source page: https://510kreport.com/device/K973988
Methodology: https://510kreport.com/methodology