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Gamma Enterprises, Inc.

United StatesFDA applicant, unverified

Devices
23

What Gamma Enterprises, Inc. makes

Gamma Enterprises, Inc. manufactures diagnostic reagents and wash solutions for laboratory testing, including creatine phosphokinase (CPK), electrolytes (potassium, calcium, chloride, sodium), uric acid, blood urea nitrogen (BUN), alkaline phosphatase, total protein, and creatinine.

The company’s portfolio is regulated under FDA’s Class I and Class II device classifications, with devices listed via the 510(k) pathway. Gamma Enterprises, Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

Newest first, rows 1-23 of 23

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  • Creatine Phosphokinase (Cpk) Ref K780504

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

  • Potassium Ref K771837

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

  • Calcium Ref K771831

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

  • Chloride Ref K771832

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

  • Sodium Ref K771839

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

  • Gamma Smac Reagents Ref K790578

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

  • Total Protein Ref K771841

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

  • Uric Acid Ref K771842

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

  • Blood Urea Nitrogen Bun Ref K771830

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

  • Alkaline Phosphatase Ref K771829

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

  • Wash Solutions Ref K771844

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

  • Creatinine Ref K771834

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

  • Serum Glutamic-Pyruvic Transaminase Ref K780507

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

  • Serum Glutamic-Oxaloacetic-Transaminase Ref K780505

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

  • Cholesterol Ref K771833

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

  • Carbon Dioxide Reagents Ref K780506

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

  • Salonmay Bustline Increaser Ref K770082

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

  • Wetting Agents Ref K771843

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

  • Lactate Dehydrogenase Ref K771836

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

  • Inorganic Phosphorus Ref K771835

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

  • Total Bilirubin Ref K771840

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

  • Serum Iron Ref K771838

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

  • Albumin Ref K771828

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

Rows 1-23 of 23

Frequently asked questions

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

The registry currently lists 23 devices for Gamma Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gamma Enterprises, Inc.'s devices?

Among its 23 most recently registered devices, Gamma Enterprises, Inc. has devices listed in FDA 510(k) (23 devices).

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

Among its 23 most recently registered devices, the classes recorded for Gamma Enterprises, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Gamma Enterprises, Inc. include CREATINE PHOSPHOKINASE (CPK), POTASSIUM, CALCIUM and CHLORIDE.

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