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

    PROPARAFLU+ASSAY

    K Number: K091053 · Decision Nov 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    221

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    Basic Information

    Device Name
    PROPARAFLU+ASSAY
    K Number
    K091053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodesse, Inc.
    Date Received
    April 13, 2009
    Decision Date
    November 20, 2009
    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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