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

    PRO HMPV+ ASSAY

    K Number: K082688 · Decision Nov 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    53

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    Basic Information

    Device Name
    PRO HMPV+ ASSAY
    K Number
    K082688
    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
    September 15, 2008
    Decision Date
    November 7, 2008
    Product Code
    OEM
    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
    OEM Human Metapneumovirus (Hmpv) Rna Assay System

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