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

    FLEET DETECTATEST

    K Number: K812728 · Decision Jul 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    2
    Review Days
    277

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    Basic Information

    Device Name
    FLEET DETECTATEST
    K Number
    K812728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    C.B. Fleet Co., Inc.
    Date Received
    September 28, 1981
    Decision Date
    July 2, 1982
    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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