BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA

    K Number: K930020 · Decision Jul 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    126
    Review Days
    193

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    Basic Information

    Device Name
    ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
    K Number
    K930020
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    January 4, 1993
    Decision Date
    July 16, 1993
    Product Code
    LJN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJN Antibody Igm, If, Epstein-Barr Virus

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