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    K Number
    K041234
    Device Name
    HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    2004-06-10

    (31 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 201 Analyzer. The HemoCue® Hb 201 DM System is used for the quantitative determination of hemoglobin in blood using specially designed analyzer, the HemoCue® Hb 201 DM Analyzer and specially designed microcuvettes, the HemoCue® Hb 201 Microcuvettes. The HemoCue Hb 201 DM Analyzer is only to be used with HemoCue® Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201 DM Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. The use of any other device in the HemoCue Hb 201 DM Analyzer except the HemoCue 201 Microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequence. The HemoCue Hb 201 microcuvettes are for in vitro use only.
    Device Description
    Not Found
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    K Number
    K041230
    Device Name
    CLINICAL LABORATORY ANALYZING SYSTEM
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    2004-05-20

    (10 days)

    Product Code
    LFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
    Device Description
    The HemoCue Glucose 201 DM System consists of the HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes.
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    K Number
    K032203
    Device Name
    HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    2003-08-25

    (38 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K020935
    Device Name
    HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    2002-04-03

    (12 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
    Device Description
    HemoCue® Glucose 201 System
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    K Number
    K962415
    Device Name
    HEMOCUE B-GLCOSE SYSTEM
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    1996-10-15

    (125 days)

    Product Code
    LFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961312
    Device Name
    HEMOCUE B-HEMOGLOBIN SYSTEM
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    1996-09-24

    (173 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961311
    Device Name
    HEMOCUE B-GLUCOSE SYSTEM
    Manufacturer
    HEMOCUE, INC.
    Date Cleared
    1996-08-23

    (141 days)

    Product Code
    LFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMOCUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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