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

    Solana Bordetella Complete Assay

    K Number: K181029 · Decision Jul 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    37
    Review Days
    88

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    Basic Information

    Device Name
    Solana Bordetella Complete Assay
    K Number
    K181029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corporation
    Date Received
    April 18, 2018
    Decision Date
    July 15, 2018
    Product Code
    OZZ
    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
    OZZ Bordetella Pertussis Dna Assay System

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