# K801834: Wako HDL Cholesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Wako Pure Chemical Industries, Ltd.
- Decided: Sep 16, 1980 after 46 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K063852: Accessa Cholesterol Panel (2007), 0 descendants of its own
- K963847: Wako Direct HDL-C (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K801834
Methodology: https://510kreport.com/methodology