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

    FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG

    K Number: K880996 · Decision May 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    30
    Review Days
    66

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    Basic Information

    Device Name
    FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
    K Number
    K880996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Whittaker Bioproducts, Inc.
    Date Received
    March 8, 1988
    Decision Date
    May 13, 1988
    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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