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

    OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM

    K Number: K113566 · Decision Jun 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    4
    Review Days
    202

    Basic Information

    Device Name
    OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
    K Number
    K113566
    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, INC.
    Date Received
    December 2, 2011
    Decision Date
    June 21, 2012
    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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