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

    HEMOCCULT-C

    K Number: K832311 · Decision Feb 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    228

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    Basic Information

    Device Name
    HEMOCCULT-C
    K Number
    K832311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Menley & James Laboratories
    Date Received
    July 14, 1983
    Decision Date
    February 27, 1984
    Product Code
    KHE
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    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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