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

    CHANG MEDIUM

    K Number: K812820 · Decision Nov 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    366
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    CHANG MEDIUM
    K Number
    K812820
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    October 7, 1981
    Decision Date
    November 10, 1981
    Product Code
    KIT
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIT Media And Components, Synthetic Cell And Tissue Culture

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