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510(k) Data Aggregation

    K Number
    K001352
    Device Name
    REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2001-04-09

    (346 days)

    Product Code
    DHC
    Regulation Number
    866.5820
    Why did this record match?
    Product Code :

    DHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001398
    Device Name
    REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2001-03-30

    (331 days)

    Product Code
    DHC
    Regulation Number
    866.5820
    Why did this record match?
    Product Code :

    DHC

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

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