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American Monitor Corp.

United StatesFDA applicant, unverified

Devices
73

What American Monitor Corp. makes

American Monitor Corp. manufactures diagnostic reagent sets and test systems for clinical chemistry, including assays for theophylline, ethanol, serum iron, lactate dehydrogenase (LDH), gamma-glutamyltransferase, triglycerides, phosphorus, SGOT/AST, uric acid, creatine phosphokinase (CPK), and carbon dioxide content. Their products use enzymatic and kinetic methods for laboratory analysis, such as the GPO-Grinder method for triglycerides and blue 610 absorbance-based assays.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. These products are intended for in vitro diagnostic use in clinical laboratories and are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.

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

Catalogue73

Newest first, rows 51-73 of 73

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  • Enzymatic CO2 Reagent Set Ref K882497

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

  • Enzymatic CO2 Ref K833724

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

  • Neochrome(R) Iii Glucose Ref K892002

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

  • Kda Micro Chemical Analyzer Ref K800572

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

  • American Monitor Magnesium #'s 1036&4021 Ref K802091

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

  • Qualify I & Ii Amer. Monitor 2009 & 2010 Ref K843611

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

  • Durazyme Cpk Ref K833781

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

  • Enzymatic Cholesterol Reagent Set Ref K770909

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

  • Sodium And Potassium By Ion Selective Ref K873074

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

  • Kinetic Alkaline Phosphatase Ref K834033

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

  • Therapeutic Drug Monitoring Control Set Ref K862963

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

  • Cholinesterase Reagent System Ref K771024

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

  • Durazyme Got/Ast Ref K800116

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

  • Reagent System Ref K770242

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

  • Omni-Fal I & Ii Ref K833009

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

  • Durazyme Urea Nitrogen Ref K852292

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

  • Ethanol Calibrator Ref K872181

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

  • Phosphorus Il Ref K820832

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

  • Enzymatic CO2 Ref K822079

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

  • Bio-Interference Blanking Material, Am Cat. #2052 Ref K872073

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

  • Reagent System Ref K770504

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

  • Bio Interference Blanking Material Ref K823687

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

  • Cholesterol Reagent Set Ref K893479

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

Rows 51-73 of 73

Showing 51-73 of 73