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

    CARE FECAL OCCULT BLOOD TEST, MODEL KT313

    K Number: K051806 · Decision Oct 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    CARE FECAL OCCULT BLOOD TEST, MODEL KT313
    K Number
    K051806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    EPITOPE DIAGNOSTICS, INC.
    Date Received
    July 5, 2005
    Decision Date
    October 3, 2005
    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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