# Hyperion, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 8 (1984–2002): 8 510(k) clearances
- Product codes: JJQ (4), DHN (2), FPA (1), JQW (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bion Ent., Ltd.: 1 (https://510kreport.com/company/bion-ent)

## Its most-cited devices
- K013213: Hyperion Visiquant Ana Test Kit (2002), cited by 1

## Recent decisions
- K022800: Visiquant Anti-Nuclear Antibody Test System (Nov 25, 2002)
- K013213: Hyperion Visiquant Ana Test Kit (Jun 4, 2002)
- K935983: Microreader 4 (Dec 9, 1994)
- K913809: HY-Prep System (Jan 15, 1992)
- K873138: Micro-Reader II (Sep 14, 1987)
- K864060: Micro-Reader (Nov 28, 1986)
- K855149: Computing Spectrophotometer Bio-Chemistry Analyzer (Feb 11, 1986)
- K834071: Lymphangiography Set Special 30G (Jan 25, 1984)

Source page: https://510kreport.com/company/hyperion