# K872845: Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum

- Pathway: 510(k) (Traditional)
- Applicant: Bion Ent., Ltd.
- Decided: Aug 17, 1987 after 28 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K013213: Hyperion Visiquant Ana Test Kit (2002), 1 descendant of its own
- K042680: Rhigene Hep-Ana Test System (2004), 0 descendants of its own
- K022800: Visiquant Anti-Nuclear Antibody Test System (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K872845
Methodology: https://510kreport.com/methodology