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

    EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL

    K Number: K850431 · Decision Jun 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    9
    Review Days
    133

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    Basic Information

    Device Name
    EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
    K Number
    K850431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Nms Pharmaceuticals, Inc.
    Date Received
    February 4, 1985
    Decision Date
    June 17, 1985
    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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