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

    Francisella tularensis Real-time PCR assay

    K Number: K252072 · Decision Sep 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    30
    Review Days
    91

    Basic Information

    Device Name
    Francisella tularensis Real-time PCR assay
    K Number
    K252072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4000
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    July 1, 2025
    Decision Date
    September 30, 2025
    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

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