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510(k) Data Aggregation

    K Number
    K963909
    Device Name
    HEMOCUE GLUCOLIN
    Manufacturer
    DIRECT SOLUTIONS
    Date Cleared
    1996-11-08

    (39 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIRECT SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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?
    Applicant Name (Manufacturer) :

    DIRECT SOLUTIONS

    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
    K964053
    Device Name
    HEMOCUE GLUCOTROL
    Manufacturer
    DIRECT SOLUTIONS
    Date Cleared
    1996-11-01

    (32 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIRECT SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
    Device Description
    Not Found
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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?
    Applicant Name (Manufacturer) :

    DIRECT SOLUTIONS

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

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