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510(k) Data Aggregation

    K Number
    K011058
    Date Cleared
    2001-10-23

    (200 days)

    Product Code
    Regulation Number
    870.1130
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K010794
    Date Cleared
    2001-05-10

    (55 days)

    Product Code
    Regulation Number
    870.2920
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN MEDICAL TECHNOLOGIES LTD.

    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

    K Number
    K002310
    Date Cleared
    2000-10-25

    (86 days)

    Product Code
    Regulation Number
    870.2920
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN MEDICAL TECHNOLOGIES LTD.

    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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