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

    Rickettsia Real-time PCR Assay

    K Number: K170940 · Decision Jun 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    Rickettsia Real-time PCR Assay
    K Number
    K170940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3316
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers For Disease Control and Prevention (CDC)
    Date Received
    March 30, 2017
    Decision Date
    June 29, 2017
    Product Code
    PVQ
    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
    PVQ Rickettsia Spp. Nucleic Acid Based Detection Assay

    Other Clearances by Centers For Disease Control and Prevention (CDC)

    K Number Device Name
    K181736 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
    DEN160016 Variola virus Real-Time PCR Assay
    K161556 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
    K153148 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
    K140426 ANTHRACIS REAL-TIME PCR ASSAY