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

    QUANTA LITE GBM ELISA

    K Number: K984336 · Decision Feb 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    5
    Applicant Total
    138
    Review Days
    67

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    Basic Information

    Device Name
    QUANTA LITE GBM ELISA
    K Number
    K984336
    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
    December 3, 1998
    Decision Date
    February 8, 1999
    Product Code
    MVJ
    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
    MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

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