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510(k) Data Aggregation

    K Number
    K963111
    Device Name
    COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
    Manufacturer
    CHROMOGENIX AB
    Date Cleared
    1996-12-23

    (133 days)

    Product Code
    GGW
    Regulation Number
    864.7925
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHROMOGENIX AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    diagnosis of the APC resistance phenotype
    Device Description
    COATEST APC RESISTANCE V or V S test is based on the use of activated protein C in an APTT clotting assay, as was the original test kit.
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    K Number
    K952515
    Device Name
    COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
    Manufacturer
    CHROMOGENIX AB
    Date Cleared
    1996-01-23

    (237 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHROMOGENIX AB

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