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

    OC-SENSOR DIANA IFOB TEST

    K Number: K092330 · Decision Jan 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    157

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    Basic Information

    Device Name
    OC-SENSOR DIANA IFOB TEST
    K Number
    K092330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymedco Cancer Diagnostics, LLC
    Date Received
    August 4, 2009
    Decision Date
    January 8, 2010
    Product Code
    OOX
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    OOX Automated Occult Blood Analyzer

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