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510(k) Data Aggregation

    K Number
    K041635
    Device Name
    G5 I HBA1C TEST, G5 II HBA1C TEST
    Manufacturer
    PROVALIS DIAGNOSTICS LTD.
    Date Cleared
    2004-08-16

    (61 days)

    Product Code
    LCP, GGM
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROVALIS DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The G5 I HbA₁c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA₁c in capillary blood taken from a finger prick or whole blood in EDTA. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 I HbA₁c assay is intended for use in a physicians/doctors office. The assay is not intended for use as a home use or for self-testing. The G5 II HbA1c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 II HbA1c assay is intended for use as a prescription home use test.
    Device Description
    Instrument read, single use in vitro test for the quantitative determination of glycated haemoglobin (GHb) in diabetics.
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    K Number
    K011933
    Device Name
    GLYCOSAL II HBA 1C TEST
    Manufacturer
    PROVALIS DIAGNOSTICS LTD.
    Date Cleared
    2001-11-02

    (135 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROVALIS DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glycosal™ II HbA1c test is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA1c test is intended for use as a prescription home use test.
    Device Description
    Instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics.
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    K Number
    K001392
    Device Name
    GLYCOSAL HBA1C TEST
    Manufacturer
    PROVALIS DIAGNOSTICS LTD.
    Date Cleared
    2000-08-21

    (110 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROVALIS DIAGNOSTICS LTD.

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