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

    EBV-EA(D) IGG ELISA TEST

    K Number: K940093 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    57
    Review Days
    616

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    Basic Information

    Device Name
    EBV-EA(D) IGG ELISA TEST
    K Number
    K940093
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gull Laboratories, Inc.
    Date Received
    January 7, 1994
    Decision Date
    September 15, 1995
    Product Code
    LSE
    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
    LSE Epstein-Barr Virus, Other

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