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Alpkem Corp.

United StatesFDA applicant, unverified

Devices
33

What Alpkem Corp. makes

Alpkem Corp. manufactures automated clinical analyzers, including the VX-1000 and RFA-300 Rapid Flow Analyzer with computer integration, designed for laboratory chemistry testing. Their product line also includes a range of reagents for biochemical assays, such as glucose (GLU-GOD), triglycerides, cholesterol, creatinine, and bilirubin measurements. These reagents support automated workflows in clinical diagnostics, enabling rapid and precise sample analysis.

The company’s devices fall under FDA Class I and Class II classifications, with many products cleared via the 510(k) pathway. Their analyzers and reagents are listed in the FDA 510(k) registry, reflecting regulatory compliance for use in clinical settings. Alpkem Corp. is headquartered in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue33

Newest first, rows 1-33 of 33

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  • Ast Aspartate Aminotransferase Reagent Ref K851994

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

  • Alp(Alkaline)(Phosphatase) Reagent Ref K851998

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

  • Clinalyzer Model Vx-1000 Ref K851638

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

  • Mg Reagent Ref K852005

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

  • Rfa-300 Rapid Flow Analyzer W/Computer Ref K883020

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

  • Alb Bcg Reagent Ref K852007

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

  • Triglycerides - Gpo Reagent Ref K890337

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

  • Glu(God) Reagent Ref K851992

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

  • Rfa-300 Rapid Flow Analyzer W/Computer Ref K851542

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

  • Ld-L Reagent Ref K851996

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

  • Sodium Hydroxide Solution, Creatinine Reag./Dilu. Ref K890335

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

  • T-Bil Reagent, D-Bil Reagent, Sodium Nitrite & Sul Ref K852008

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

  • Ck-Nac Reagent Ref K852000

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

  • Total Cholesterol Reagent Ref K890334

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

  • Total Galactose Ref K894011

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

  • Cre Buffer Cre Dye Ref K851993

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

  • Magnesium (Substrate, Enzyme, Reagent) Ref K860367

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

  • Rfa/2 Rapid Flow Analyzer W/Computer Ref K890332

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

  • T-Cho Reagent Ref K852009

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

  • Alt (Alanine Amino-Thransferase)Reagent Ref K851995

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

  • Internal Standard Solution, External Standard Solu Ref K851990

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

  • Ca Buffer Ca Dye Ref K852002

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

  • Amy Reagent Ref K852001

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

  • Tp Biuret Reagent Ref K852006

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

  • Ua(Uricase) Reagent Ref K852004

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

  • Glucose (God) Reagent Ref K890336

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

  • Tgl Reagent Ref K852010

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

  • Phenylalanine (Ninhydrin Reaction) Ref K891070

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

  • Albumin Reagent Ref K890333

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

  • G-Gt Reagent Ref K851999

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

  • Ip Acid Reagent Ip Moly Bdate Reagent Ref K852003

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

  • Un(Urease)Reagent Un(A-Keto)Reagent Ref K851991

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

  • Ld-P Reagent Ref K851997

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

Rows 1-33 of 33

Frequently asked questions

How many devices does Alpkem Corp. have in the registry?

The registry currently lists 33 devices for Alpkem Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Alpkem Corp.'s devices?

Among its 33 most recently registered devices, Alpkem Corp. has devices listed in FDA 510(k) (33 devices).

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

Among its 33 most recently registered devices, the classes recorded for Alpkem Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Alpkem Corp. in the registry?

The most recently registered devices listed for Alpkem Corp. include AST ASPARTATE AMINOTRANSFERASE REAGENT, ALP(ALKALINE)(PHOSPHATASE) REAGENT, CLINALYZER MODEL VX-1000 and MG REAGENT.

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