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510(k) Data Aggregation

    K Number
    K964192
    Device Name
    ARDENT NON GAMMA-2 70
    Date Cleared
    1997-01-06

    (81 days)

    Product Code
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARDENT PRODUCTION DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K964775
    Device Name
    ARDENT FUTURA NON GAMMA-2
    Date Cleared
    1996-12-10

    (54 days)

    Product Code
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARDENT PRODUCTION DEVELOPMENT

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

    Ask a specific question about this device

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