# K954778: Cholestech LDX System

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Nov 24, 1995 after 66 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K080125: Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K954778
Methodology: https://510kreport.com/methodology