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Harleco Diagnostics

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Devices
23

What Harleco Diagnostics makes

Harleco Diagnostics manufactures point-of-care and laboratory chemistry analyzers, including the ULTRACHEM series for measuring total bilirubin, total protein, and electrolytes, as well as the ULTRAZYME PLUS line for cardiac enzymes (CPK, CK-I, CK-MB), liver enzymes (GOT, GPT), amylase, and glucose. The portfolio also includes specific reagents for blood urea nitrogen (BUN) and albumin assays, designed for clinical chemistry testing.

The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as Class I and Class II. These analyzers are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Harleco Diagnostics operates from the United States.

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

Catalogue23

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  • Ultrachem T-Bili Ref K821873

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

  • Ultrachem T.P. Ref K821879

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

  • Ultrachem Tri-Es Ref K821875

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

  • Ultrachem Bun-Uv, 65080 & 65081 Ref K822323

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

  • Cpk Ultrazyme Plus Ref K770694

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

  • Ultrazyme Plus Ck-I Ref K821883

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

  • Ultrazyme Plus 2GT Ref K821871

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

  • Ultrazyme Plus Got Ref K821876

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

  • Ultrazyme Plus Amyl Ref K821869

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

  • Ultrazyme Plus Gpt Ref K821882

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

  • Ultra Chem Alb Ref K821880

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

  • Ultrachem E-Glu Ref K821868

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

  • Ultrachem Uric Acid Aidh Ref K821872

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

  • Ultrazyme Plus Hbd Ref K821877

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

  • Ultrazyme Plus Ldh Ref K821878

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

  • Ultrachem Gluc-Dh Ref K821867

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

  • Ultrachem Crea Ref K821881

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

  • Uric Acid Standard, 8mg/Dl #65078 Ref K823147

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

  • Triglyceride Calibrator Ref K822852

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

  • Ultrazyme Plus Alp Ref K821870

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

  • Auto-Albumin Reag For Gilford 3400E Anal Ref K761026

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

  • Ultrachem Phos Ref K821874

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

  • Ldh Ultrazyme Plus Ref K770613

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

Rows 1-23 of 23

Frequently asked questions

How many devices does Harleco Diagnostics have in the registry?

The registry currently lists 23 devices for Harleco Diagnostics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Harleco Diagnostics's devices?

Among its 23 most recently registered devices, Harleco Diagnostics has devices listed in FDA 510(k) (23 devices).

What risk classes do Harleco Diagnostics's devices fall under?

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

What are the newest devices from Harleco Diagnostics in the registry?

The most recently registered devices listed for Harleco Diagnostics include ULTRACHEM T-BILI, ULTRACHEM T.P., ULTRACHEM TRI-ES and ULTRACHEM BUN-UV, 65080 & 65081.

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