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

    STEMPRO MSC SFM

    K Number: K103302 · Decision Feb 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    101

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    Basic Information

    Device Name
    STEMPRO MSC SFM
    K Number
    K103302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5885
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Technologies Corporation
    Date Received
    November 9, 2010
    Decision Date
    February 18, 2011
    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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