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510(k) Data Aggregation

    K Number
    K192842
    Device Name
    HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
    Manufacturer
    Eurotrol B.V.
    Date Cleared
    2019-11-15

    (43 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
    Device Description
    HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available. HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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    K Number
    K182744
    Device Name
    HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2019-02-01

    (126 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
    Device Description
    HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available. HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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    K Number
    K070546
    Device Name
    LYPHOCHEK DIABETES CONTROL
    Manufacturer
    Bio-Rad Laboratories
    Date Cleared
    2007-04-02

    (35 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyphochek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    This is a lyophilized product prepared from human whole blood containing preservatives and stabilizers.
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    K Number
    K070334
    Device Name
    R&D SICKLE QC CONTROL
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2007-03-29

    (52 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
    Device Description
    Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits. The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
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    K Number
    K052838
    Device Name
    LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
    Manufacturer
    BIO-RAD
    Date Cleared
    2005-11-09

    (33 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    This is a liquid product prepared from human whole blood containing preservatives and stabilizers.
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    K Number
    K032791
    Device Name
    GLYCOHEMOSURE HBA1C CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2003-10-30

    (52 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.
    Device Description
    The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.
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    K Number
    K003030
    Device Name
    LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
    Manufacturer
    BIO-RAD
    Date Cleared
    2000-11-29

    (62 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993321
    Device Name
    R&D HGB/GLC WHOLE BLOOD CONTROL
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    1999-11-12

    (39 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood. R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
    Device Description
    The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.
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    K Number
    K964052
    Device Name
    HEMOCUE HEMOTROL
    Manufacturer
    DIRECT SOLUTIONS
    Date Cleared
    1996-11-06

    (37 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoCue HemoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are included for comparison.
    Device Description
    These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.
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    K Number
    K963908
    Device Name
    HEMOCUE HEMOLIN
    Manufacturer
    DIRECT SOLUTIONS
    Date Cleared
    1996-10-16

    (16 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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