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

    ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

    K Number: K101831 · Decision Oct 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    49
    Review Days
    92

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    Basic Information

    Device Name
    ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
    K Number
    K101831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionostics, Inc.
    Date Received
    July 1, 2010
    Decision Date
    October 1, 2010
    Product Code
    OSL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OSL Control, Fecal Occult Blood

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