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

    MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

    K Number: K082150 · Decision Feb 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    189

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    Basic Information

    Device Name
    MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
    K Number
    K082150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.4070
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Preanalytix GmbH
    Date Received
    July 30, 2008
    Decision Date
    February 4, 2009
    Product Code
    NTW
    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
    NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NTW), ordered by most recent decision date.

    PAXGENE BLOOD RNA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Preanalytix GmbH

    K Number Device Name
    K231469 PAXgene® Blood DNA Tube
    K142821 PAXgene Blood DNA Tube
    DEN050003 PAXGENE BLOOD RNA SYSTEM