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

    GAS GENERATING KIT, CO2

    K Number: K820010 · Decision Jan 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    17
    Applicant Total
    93
    Review Days
    23

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    Basic Information

    Device Name
    GAS GENERATING KIT, CO2
    K Number
    K820010
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2580
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    January 5, 1982
    Decision Date
    January 28, 1982
    Product Code
    KZJ
    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
    KZJ Device, Gas Generating

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