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

    Francisella tularensis Real-time PCR Assay

    K Number: K260812 · Decision Mar 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    30
    Review Days
    17

    Basic Information

    Device Name
    Francisella tularensis Real-time PCR Assay
    K Number
    K260812
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.4000
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    March 13, 2026
    Decision Date
    March 30, 2026
    Product Code
    SGA
    Advisory Committee
    Immunology
    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
    SGA Biothreat Microbial Agent Nucleic Acid Detection Test

    Similar 510(k) Clearances

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

    Francisella tularensis Real-time PCR assay

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

    Other Clearances by Centers for Disease Control and Prevention

    K Number Device Name
    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
    K190302 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 B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
    Search all 30 clearances from Centers for Disease Control and Prevention →