# K080125: Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jul 18, 2008 after 183 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
Longest line of descent: 1 generation back to K946067 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954778: Cholestech LDX System, Cholestech Corp. (1995) Summary page 2.
- K946067: Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose Panel, Cholestech Corp. (1995) Summary page 2.

## Indications for use
The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

Source page: https://510kreport.com/device/K080125
Methodology: https://510kreport.com/methodology