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

    NOVA LITE ENDOMYSIAL

    K Number: K980312 · Decision Apr 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    138
    Review Days
    65

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    Basic Information

    Device Name
    NOVA LITE ENDOMYSIAL
    K Number
    K980312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    January 27, 1998
    Decision Date
    April 2, 1998
    Product Code
    DBL
    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
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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