# K935162: Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Nov 10, 1994 after 377 days
- Product code: JHO (Electrophoretic Separation, Lipoproteins)
- 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
- K991083: RLP Cholesterol Immunoseparation Assay (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K935162
Methodology: https://510kreport.com/methodology