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

    PREZAPAK L ARTERIAL BLOOD SAMPLING KIT

    K Number: K801015 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
    K Number
    K801015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kimble-Terumo, Inc.
    Date Received
    April 29, 1980
    Decision Date
    May 14, 1980
    Product Code
    GIM
    Advisory Committee
    Clinical Chemistry
    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
    GIM Tubes, Vacuum Sample, With Anticoagulant

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