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

    PAXGENE BLOOD RNA SYSTEM

    K Number: DEN050003 · Decision Apr 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    PAXGENE BLOOD RNA SYSTEM
    K Number
    DEN050003
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.4070
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Preanalytix GmbH
    Date Received
    February 28, 2005
    Decision Date
    April 18, 2005
    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.

    MODIFICATION TO 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
    K082150 MODIFICATION TO PAXGENE BLOOD RNA SYSTEM