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Environmental Chemical Specialties

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Devices
15

What Environmental Chemical Specialties makes

The company manufactures diagnostic controls and test kits for clinical chemistry and urinalysis, including quantitative urine controls, lipid and enzyme assays, glucose monitoring, and therapeutic drug monitoring controls for anticonvulsants and anti-arrhythmics. Products also cover carcinogenic antigen controls, uric acid testing, and spinal fluid reference standards for human use.

These devices are regulated under FDA’s 510(k) pathway as Class I or Class II medical devices, depending on risk level. The portfolio is listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.

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

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  • Carcinoembryonic Antigen (Cea) Control Ref K792377

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

  • Lypoprotein Cholesterol Test Kit Ref K780173

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

  • Tdm Anti-Convulsant Control Levels I-Ii Ref K811811

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

  • Glucose Kit Ref K761320

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

  • Quantitative Control Urine Ii (Human) Ref K792376

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

  • Gamma-Glutamyl Transpeptidase (Ggt) Ref K803089

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

  • Anti-Arrhythmic Control Levels I & Ii Ref K811809

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

  • Uric Acid Test Ref K811810

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

  • Triglyceride Kit Ref K771068

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

  • Spinal Fluid Control(Human) Ref K801854

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

  • Elevated Lipid Control Ref K792375

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

  • Quantitative Control Urine I (Human) Ref K792374

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

  • Anemia Control Ref K812635

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

  • Cholesterol Kit Ref K771067

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

  • Total Protein Test Ref K801061

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

Rows 1-15 of 15

Frequently asked questions

How many devices does Environmental Chemical Specialties have in the registry?

The registry currently lists 15 devices for Environmental Chemical Specialties. Devices recorded under merged duplicate company entries are counted once.

Which registries list Environmental Chemical Specialties's devices?

Among its 15 most recently registered devices, Environmental Chemical Specialties has devices listed in FDA 510(k) (15 devices).

What risk classes do Environmental Chemical Specialties's devices fall under?

Among its 15 most recently registered devices, the classes recorded for Environmental Chemical Specialties's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Environmental Chemical Specialties in the registry?

The most recently registered devices listed for Environmental Chemical Specialties include CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL, LYPOPROTEIN CHOLESTEROL TEST KIT, TDM ANTI-CONVULSANT CONTROL LEVELS I-II and GLUCOSE KIT.

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