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

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

    K Number: K221834 · Decision Jun 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    30
    Review Days
    1

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    Basic Information

    Device Name
    Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K Number
    K221834
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3315
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    June 23, 2022
    Decision Date
    June 24, 2022
    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

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    K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
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