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

    FIAX TEST KIT FOR MUMPS-G ANTIBODIES

    K Number: K872733 · Decision Oct 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    30
    Review Days
    89

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    Basic Information

    Device Name
    FIAX TEST KIT FOR MUMPS-G ANTIBODIES
    K Number
    K872733
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3380
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Whittaker Bioproducts, Inc.
    Date Received
    July 9, 1987
    Decision Date
    October 6, 1987
    Product Code
    GRB
    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
    GRB Antiserum, Cf, Mumps Virus

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