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Hycel, Inc.

United StatesFDA applicant, unverified

Devices
22

What Hycel, Inc. makes

Hycel, Inc. manufactures a range of in vitro diagnostic tests and related laboratory equipment, including albumin, triglyceride, creatinine, uric acid, calcium, ketosteroid, and LDH assays, as well as a CPK-INT test and a reformulated HMA calcium test. The company also offers a high‑purity instrument‑grade propane product, a hematology data analyzer (Royco Model 970), and counting devices such as the Hycel Counter 222 and the Counter 700/HC‑700 HemO 0 Ref.

These devices are classified as Class I or Class II medical devices and are listed in the FDA 510(k) database. Hycel, Inc. is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue22

Newest first, rows 1-22 of 22

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  • Albumin Test, Hma Albumin Test Ref K771259

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

  • Hycel Trigyceride Ii Test Ref K802422

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

  • Creatinine Test, Super Seventeen Ref K770643

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

  • Propane, High Purity, Instrument Grade Ref K770393

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

  • Royco Model 970 Hematology Data Analyzer Ref K780946

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

  • Hma Uric Acid Test Ref K781004

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

  • Cpk-Int Test Ref K771154

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

  • Test, Reformulated Hycel Hma Calcium Ref K760468

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

  • Hycel Counter 222 Ref K782101

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

  • Ketosteroid Test, Hycel-17 Ref K782116

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

  • Counter 700 & Hc-700 Hemo 0 Ref. Ref K771107

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

  • Ldh-Int Test Ref K771343

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

  • Hycel Counter 211 Ref K782102

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

  • Hycel Counter 333 Ref K782100

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

  • Platelet Counter & Hematocrit Acces. Ref K771353

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

  • 17-Hydroxy Test Ref K772426

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

  • Test, Ferrozine Iron & Iron Binding Ref K770748

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

  • Direct Urea Nitrogen Test Ref K780262

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

  • Hemotology Produ&Ts (5 In All) Ref K770803

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

  • Hycel Ldh-Int Test Ref K782176

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

  • Lelective Kinetic System-60 Ref K780464

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

  • Hycel M Ref K790335

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

Rows 1-22 of 22

Frequently asked questions

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

The registry currently lists 22 devices for Hycel, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hycel, Inc.'s devices?

Among its 22 most recently registered devices, Hycel, Inc. has devices listed in FDA 510(k) (22 devices).

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

Among its 22 most recently registered devices, the classes recorded for Hycel, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Hycel, Inc. include ALBUMIN TEST, HMA ALBUMIN TEST, HYCEL TRIGYCERIDE II TEST, CREATININE TEST, SUPER SEVENTEEN and PROPANE, HIGH PURITY, INSTRUMENT GRADE.

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