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510(k) Data Aggregation

    K Number
    K232543
    Device Name
    MSC SFM
    Manufacturer
    Yocon Biology Technology Company
    Date Cleared
    2024-09-06

    (381 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yocon Biology Technology Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.
    Device Description
    MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.
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