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

    MODIFICATION TO PROFLU+ ASSAY

    K Number: K081030 · Decision May 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    78
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO PROFLU+ ASSAY
    K Number
    K081030
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodesse, Inc.
    Date Received
    April 11, 2008
    Decision Date
    May 2, 2008
    Product Code
    OCC
    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
    OCC Respiratory Virus Panel Nucleic Acid Assay System

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    Other Clearances by Prodesse, Inc.

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