BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

    K Number: K100031 · Decision Jul 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    8
    Review Days
    194

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    Basic Information

    Device Name
    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
    K Number
    K100031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostic, Inc.
    Date Received
    January 6, 2010
    Decision Date
    July 19, 2010
    Product Code
    KHE
    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
    KHE Reagent, Occult Blood

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