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

    INTROL CF PANEL I CONTROL

    K Number: DEN060007 · Decision Oct 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    15
    Review Days
    59

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    Basic Information

    Device Name
    INTROL CF PANEL I CONTROL
    K Number
    DEN060007
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.5910
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Maine Molecular Quality Controls, Inc.
    Date Received
    August 14, 2006
    Decision Date
    October 12, 2006
    Product Code
    NZB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZB Quality Control Material, Genetics, Dna

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