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

    NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

    K Number: DEN070001 · Decision Sep 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    30
    Review Days
    4266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
    K Number
    DEN070001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3315
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    January 16, 2007
    Decision Date
    September 21, 2018
    Product Code
    PBK
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBK Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

    Similar 510(k) Clearances

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

    Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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

    Other Clearances by Centers for Disease Control and Prevention

    K Number Device Name
    K260812 Francisella tularensis Real-time PCR Assay
    K252072 Francisella tularensis Real-time PCR assay
    K243274 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K243931 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
    K222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K200370 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
    K192871 B. anthracis Real-time PCR Assay
    Search all 30 clearances from Centers for Disease Control and Prevention →