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510(k) Data Aggregation

    K Number
    K003194
    Manufacturer
    Date Cleared
    2000-10-26

    (14 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K000605
    Manufacturer
    Date Cleared
    2000-08-17

    (176 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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