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

    EBV IGM TEST

    K Number: K822734 · Decision Dec 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    57
    Review Days
    91

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    Basic Information

    Device Name
    EBV IGM TEST
    K Number
    K822734
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gull Laboratories, Inc.
    Date Received
    September 9, 1982
    Decision Date
    December 9, 1982
    Product Code
    JRY
    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
    JRY Antiserum, Fluorescent, Epstein-Barr Virus

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