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

    EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST

    K Number: K911571 · Decision Jun 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    126
    Review Days
    63

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    Basic Information

    Device Name
    EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
    K Number
    K911571
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    April 8, 1991
    Decision Date
    June 10, 1991
    Product Code
    MCD
    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
    MCD Antigen, Ebv, Capsid

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