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

    LYRA PARAINFLUENZA VIRUS ASSAY

    K Number: K141927 · Decision Oct 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    37
    Review Days
    85

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    Basic Information

    Device Name
    LYRA PARAINFLUENZA VIRUS ASSAY
    K Number
    K141927
    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
    July 16, 2014
    Decision Date
    October 9, 2014
    Product Code
    OOU
    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
    OOU Parainfluenza Multiplex Nucleic Acid Assay

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