# K833611: Titan Gel Lipoprotein Electrophoresis

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Mar 15, 1984 after 154 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.
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
- K991083: RLP Cholesterol Immunoseparation Assay (1999), 0 descendants of its own
- K960785: LFS Lipogel Assay Kit (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K833611
Methodology: https://510kreport.com/methodology