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Hyperion, Inc.

United StatesFDA applicant, unverified

Devices
8

What Hyperion, Inc. makes

Hyperion, Inc. manufactures diagnostic devices including manual and automated systems for antibody testing, such as the VisiQuant Anti-Nuclear Antibody Test System and its associated ANTA test kits. Their portfolio also includes manual and semi-automated readers like the MicroReader series for laboratory analysis, as well as a computing spectrophotometer for biochemistry assays. Additionally, they produce specialized medical imaging tools, such as a 30G lymphangiography set for radiographic procedures.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, and the company is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • Microreader 4 Ref K935983

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Micro-Reader Ii Ref K873138

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Visiquant Anti-Nuclear Antibody Test System Ref K022800

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hy-Prep System Ref K913809

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Computing Spectrophotometer Bio-Chemistry Analyzer Ref K855149

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lymphangiography Set Special 30g Ref K834071

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hyperion Visiquant Ana Test Kit Ref K013213

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro-Reader Ref K864060

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Hyperion, Inc. have in the registry?

The registry currently lists 8 devices for Hyperion, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hyperion, Inc.'s devices?

Among its 8 most recently registered devices, Hyperion, Inc. has devices listed in FDA 510(k) (8 devices).

What risk classes do Hyperion, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for Hyperion, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hyperion, Inc. in the registry?

The most recently registered devices listed for Hyperion, Inc. include MICROREADER 4, MICRO-READER II, VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM and HY-PREP SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.