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

    HERPES

    K Number: K811021 · Decision Nov 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    204

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    Basic Information

    Device Name
    HERPES
    K Number
    K811021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immuno-Diagnostic Products, Inc.
    Date Received
    April 15, 1981
    Decision Date
    November 5, 1981
    Product Code
    GQN
    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
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

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