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

    ANTHRACIS REAL-TIME PCR ASSAY

    K Number: K140426 · Decision May 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    92

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    Basic Information

    Device Name
    ANTHRACIS REAL-TIME PCR ASSAY
    K Number
    K140426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3045
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers For Disease Control and Prevention (CDC)
    Date Received
    February 19, 2014
    Decision Date
    May 22, 2014
    Product Code
    NHT
    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
    NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis

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