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

    RNARETAIN

    K Number: K113420 · Decision Mar 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    119

    Basic Information

    Device Name
    RNARETAIN
    K Number
    K113420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4070
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ASURAGEN, INC.
    Date Received
    November 18, 2011
    Decision Date
    March 16, 2012
    Product Code
    OZF
    Advisory Committee
    Immunology
    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
    OZF Tissue Rna Preservative For Collection, Storage, And Transportation

    Other Clearances by ASURAGEN, INC.

    K Number Device Name
    DEN160003 Quantidex qPCR BCR-ABL IS Kit