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

    DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

    K Number: DEN000008 · Decision Feb 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    4
    Review Days
    59

    Basic Information

    Device Name
    DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
    K Number
    DEN000008
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    876.5885
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    LIFE TECHNOLOGIES, INC.
    Date Received
    December 19, 2000
    Decision Date
    February 16, 2001
    Product Code
    NDS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDS Media, Culture, Ex Vivo, Tissue And Cell

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