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

    MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL

    K Number: K881186 · Decision May 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    53

    Basic Information

    Device Name
    MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
    K Number
    K881186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    HELPS PRODUCTS, INC.
    Date Received
    March 21, 1988
    Decision Date
    May 13, 1988
    Product Code
    GHY
    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
    GHY Hematocrit, Tube, Rack, Sealer, Holder

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GHY), ordered by most recent decision date.

    SAFECRIT PLASTIC MICROHEMATOCRIT TUBES

    FDA 510(k)
    FDA Class 2 ·Hematology
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    Other Clearances by HELPS PRODUCTS, INC.

    K Number Device Name
    K881188 BLOOD PH CAPILLARY TUBES, HEPARIN
    K881187 NATELSON TUBES, HEPARIN AND PLAIN
    K881262 CARAWAY TUBES, HEPARIN AND PLAIN