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

    H. INFLUENZA B ANTISERA FOR CIE

    K Number: K823348 · Decision Dec 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    12
    Review Days
    49

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    Basic Information

    Device Name
    H. INFLUENZA B ANTISERA FOR CIE
    K Number
    K823348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostica, Inc.
    Date Received
    November 9, 1982
    Decision Date
    December 28, 1982
    Product Code
    GRP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GRP Antisera, All Types, H. Influenza

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