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

    THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT

    K Number: K872217 · Decision Jul 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    29
    Review Days
    52

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    Basic Information

    Device Name
    THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
    K Number
    K872217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pacific Hemostasis
    Date Received
    June 9, 1987
    Decision Date
    July 31, 1987
    Product Code
    GHM
    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
    GHM Test, Sickle Cell

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