# Bion Ent., Ltd.

- Location (FDA's records): Park Ridge, IL
- FDA decisions: 14 (1980–1993): 14 510(k) clearances
- Product codes: LKT (1), DHN (1), GRA (1), LLM (1), JRY (1), LKI (1), LJN (1), LJG (1), GQH (1), IYO (1), CAR (1), GQO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Hyperion, Inc.: 1 (https://510kreport.com/company/hyperion)
- Corgenix, Inc.: 1 (https://510kreport.com/company/corgenix)

## Its most-cited devices
- K872845: Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum (1987), cited by 2

## Recent decisions
- K926066: Bion Mumps-G Antibody Test System (Jun 15, 1993)
- K901054: Bion Borrelia Burgdorferi Antigen Substrate Slide (Apr 5, 1990)
- K894622: Varicella Zoster Virus (Oct 24, 1989)
- K894623: Respiratory Syncytial Virus (Oct 16, 1989)
- K894624: Mumps Virus (Oct 16, 1989)
- K894626: Epstein-Barr Virus-Nuclear Antigen (Oct 16, 1989)
- K891785: Bion Ebv-G (Vca) Test System (Aug 31, 1989)
- K894625: Chlamydia (LGV-1) (Aug 15, 1989)

Source page: https://510kreport.com/company/bion-ent