BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARAWAY TUBES, HEPARIN AND PLAIN

    K Number: K881262 · Decision May 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    21
    Applicant Total
    4
    Review Days
    43

    Basic Information

    Device Name
    CARAWAY TUBES, HEPARIN AND PLAIN
    K Number
    K881262
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6150
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    HELPS PRODUCTS, INC.
    Date Received
    March 24, 1988
    Decision Date
    May 6, 1988
    Product Code
    GIO
    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
    GIO Tube, Collection, Capillary Blood

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    Other Clearances by HELPS PRODUCTS, INC.

    K Number Device Name
    K881188 BLOOD PH CAPILLARY TUBES, HEPARIN
    K881186 MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
    K881187 NATELSON TUBES, HEPARIN AND PLAIN