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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 1-50 of 73

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  • Monitorx Laserx Theophylline Reagent Set Ref K870277

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

  • Kinetic 610 Ethanol Ref K872180

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

  • Serum Iron-Ptf-600 Ref K831201

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

  • Kinetic Ldh, A< Blue 610 Method Ref K840006

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

  • Gamma-Glutamyltransferase Ref K890312

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

  • Enzymatic Triglycerides Gpo-Grinder Method Ref K854366

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

  • Phosphorus Ref K895999

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

  • Sgot/Ast Reagent System Ref K780443

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

  • Activated Uric Acid Ref K830616

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

  • Durazyme(R) Cpk Ref K883504

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

  • Ldh Reagent System Ref K781765

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

  • CO2 Content Ref K800111

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

  • Gamma-Gt Reagent System Ref K810434

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

  • Photometric Method, Iron (Non-Heme) (75JIY) Ref K890034

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

  • Nadh Oxidation, Ast/Sgot Ref K791679

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

  • Sgpt/Alt Reagent System Ref K780791

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

  • Sgpt Reagent Set Modification Ref K791641

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

  • Hdl Cholesterol Pretreatment Ref K852350

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

  • Durazyme Cpk Ref K821452

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

  • Aspartate Aminotranferase (Ast) Ref K896000

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

  • Durazyme Cholesterol Ref K840368

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

  • Flame Photometer Molel 4600, Kda Ref K770824

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

  • Caffeine Reagent Diazo Colorimetry Ref K802630

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

  • Ion Selective Electrodes & Reagent Sys Ref K843008

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

  • Glucose Reagent System Ref K782136

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

  • Total Protein Ref K854553

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

  • Phosphotungstate Reduction, Uric Acid Ref K813076

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

  • Serum Uibc-Ptf-600 Method Ref K831202

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

  • Durazyme Got/Ast Ref K792208

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

  • Parallel Flame Photometer & Sodium Ref K834248

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

  • Enzymatic Triglycerides Gpo-Trinder Method Ref K871301

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

  • Alanine Aminotransferase (Alt) Ref K896001

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

  • Reagent Set, Cholesterol, Cat No. 4024 Ref K770747

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

  • Kinetic Creatinine Ref K830447

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

  • Hdl Cholesterol Pretreatment Ref K834251

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

  • Parallel Chemical Analyzer Ref K803135

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

  • Uric Acid Reagent System Ref K810136

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

  • Durazyme Gpt/Alt Ref K800115

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

  • Standardize Tgcl & Tgch Ref K781376

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

  • Perspective Chemical Analyzer Ref K843610

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

  • Tptz Chloride Ref K820235

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

  • Y-Glutamyltransferase Ref K813215

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

  • Antiasthmatic Calibrators Ref K862964

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

  • Enzymatic Cholesterol Reagent System Ref K820473

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

  • Range-Chek Ref K854789

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

  • Access Chemistry Analyzer Ref K895423

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

  • Enzymatic Urea Nitrogen Reagent Set Ref K892331

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

  • Biuret (Colorimetric) Total Protein Ref K821905

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

  • Excel (Tm) Chemistry Analyzer Ref K893137

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

  • Neochrome Ii Glucose, #4044 Ref K792534

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

Rows 1-50 of 73

Showing 1-50 of 73

Frequently asked questions

How many devices does American Monitor Corp. have in the registry?

The registry currently lists 73 devices for American Monitor Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list American Monitor Corp.'s devices?

Among its 50 most recently registered devices, American Monitor Corp. has devices listed in FDA 510(k) (50 devices).

What risk classes do American Monitor Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for American Monitor Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from American Monitor Corp. in the registry?

The most recently registered devices listed for American Monitor Corp. include MONITORX LASERX THEOPHYLLINE REAGENT SET, KINETIC 610 ETHANOL, SERUM IRON-PTF-600 and KINETIC LDH, A< BLUE 610 METHOD.

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