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

    NOVA Lite DAPI dsDNA Crithidia luciliae Kit

    K Number: K192916 · Decision Dec 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    138
    Review Days
    423

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    Basic Information

    Device Name
    NOVA Lite DAPI dsDNA Crithidia luciliae Kit
    K Number
    K192916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    October 15, 2019
    Decision Date
    December 11, 2020
    Product Code
    KTL
    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
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

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