BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

    K Number: K153150 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    1
    Applicant Total
    138
    Review Days
    22

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    Basic Information

    Device Name
    AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
    K Number
    K153150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.4750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    November 2, 2015
    Decision Date
    November 24, 2015
    Product Code
    PIV
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

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