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

    FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A

    K Number: K893579 · Decision Jan 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    30
    Review Days
    252

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    Basic Information

    Device Name
    FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
    K Number
    K893579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Whittaker Bioproducts, Inc.
    Date Received
    May 9, 1989
    Decision Date
    January 16, 1990
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

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