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Analytical & Research Chemicals, Inc.

United StatesFDA applicant, unverified

Devices
12

What Analytical & Research Chemicals, Inc. makes

Analytical & Research Chemicals, Inc. manufactures diagnostic reagent kits and enzymatic procedures for laboratory testing, including colorimetric assays for glucose, cholesterol, creatinine, chloride, and urea nitrogen. Their portfolio also covers enzyme-based tests for lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and bilirubin (BCG albumin reagent).

These products are regulated under FDA’s Class I and Class II device classifications, with most authorised via the 510(k) pathway. The company’s reagents and test kits are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Glucolour Ref K781308

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

  • Urea Nitrogen Test Kit Ref K781306

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

  • Got Procedure Ref K781309

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

  • Enzymatic Cholesterol (Colorimetric Ref K823784

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

  • Direct Creatinine Procedure Ref K823806

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

  • Chloride Reagent Ref K781460

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

  • Glucose Determ. Kit Ref K781307

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

  • Ldh Procedure Ref K781323

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

  • Alkaline Phosphatase Ref K823786

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

  • Alp Test Ref K781324

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

  • Urea Nitrogen Ref K781305

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

  • Bcg Albumin Reaget Ref K781441

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Analytical & Research Chemicals, Inc. have in the registry?

The registry currently lists 12 devices for Analytical & Research Chemicals, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Analytical & Research Chemicals, Inc.'s devices?

Among its 12 most recently registered devices, Analytical & Research Chemicals, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Analytical & Research Chemicals, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Analytical & Research Chemicals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Analytical & Research Chemicals, Inc. in the registry?

The most recently registered devices listed for Analytical & Research Chemicals, Inc. include GLUCOLOUR, UREA NITROGEN TEST KIT, GOT PROCEDURE and ENZYMATIC CHOLESTEROL (COLORIMETRIC.

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