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

    INFLUENZA MAB TEST/INFLUENZA B TEST

    K Number: K913214 · Decision Dec 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    15
    Applicant Total
    57
    Review Days
    147

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    Basic Information

    Device Name
    INFLUENZA MAB TEST/INFLUENZA B TEST
    K Number
    K913214
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gull Laboratories, Inc.
    Date Received
    July 19, 1991
    Decision Date
    December 13, 1991
    Product Code
    GNW
    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
    GNW Antisera, Cf, Influenza Virus A, B, C

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