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Macomb Chemical Co.

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Devices
23

What Macomb Chemical Co. makes

Macomb Chemical Co. manufactures enzymatic reagent sets, reference sera, and control sera for clinical chemistry testing, including cholesterol, creatine phosphokinase (CPK), uric acid, urea nitrogen, and liver enzyme assays. Their products also include a rapid chemical analyzer and a spectrophotometer for laboratory use.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These products are intended for in vitro diagnostic use and are registered in the FDA’s 510(k) database.

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

Catalogue23

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  • Auto Enzymatic Cholesterol Ref K790947

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

  • Creatine Phosphokinase (Cpk) Reagent Set Ref K792533

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

  • Rapid Chem Analyzer Ii Ref K830095

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

  • Uric Acid Reference Sera Ref K780447

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

  • Enzymatic Urea Nitrogen Reagent Set Revi Ref K800719

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

  • Serum Glutamic Oxaloacetic Transaminase Ref K780013

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

  • Ldh (Uv Kinetic) Ref K781128

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

  • Macomb Lipid Control Ref K790371

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

  • Urea Nitrogen (Enzymatic) Ref K780534

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

  • Macomb Normal Control Serum Ref K791119

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

  • Serum Glutamic Pyruvic Transaminase Ref K770991

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

  • Spectrophotometer Ref K823720

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

  • P-Nitrophenyl Phosphate Ref K801086

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

  • Glucose (Hexokinase) Reagent Set Ref K792532

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

  • Enzymatic Cholesterol Ref K771820

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

  • Hdl Cholesterol Ref K780659

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

  • Normal Unassayed Control Sera Ref K780351

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

  • Alkaline Phosphatase Ref K790065

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

  • Triglyceride Reagent Set Ref K770993

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

  • Glycohemoglobin Ref K810958

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

  • Enzymatic Reagent Set, 4X250 Ml. Ref K791511

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

  • Glucose Oxidase Reagent Set Ref K791669

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

  • Macomb Nad-Nicotinamide Adenine Dinucleo Ref K800720

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

Rows 1-23 of 23

Frequently asked questions

How many devices does Macomb Chemical Co. have in the registry?

The registry currently lists 23 devices for Macomb Chemical Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Macomb Chemical Co.'s devices?

Among its 23 most recently registered devices, Macomb Chemical Co. has devices listed in FDA 510(k) (23 devices).

What risk classes do Macomb Chemical Co.'s devices fall under?

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

What are the newest devices from Macomb Chemical Co. in the registry?

The most recently registered devices listed for Macomb Chemical Co. include AUTO ENZYMATIC CHOLESTEROL, CREATINE PHOSPHOKINASE (CPK) REAGENT SET, RAPID CHEM ANALYZER II and URIC ACID REFERENCE SERA.

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