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

    KAWASUMI LABORATORY BLOOD DRAWING KIT

    K Number: K001043 · Decision May 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    KAWASUMI LABORATORY BLOOD DRAWING KIT
    K Number
    K001043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories America, Inc.
    Date Received
    March 31, 2000
    Decision Date
    May 19, 2000
    Product Code
    KSB
    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
    KSB Set, Transfer (Blood/Plasma)

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    Other Clearances by Kawasumi Laboratories America, Inc.

    K Number Device Name
    K102890 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
    K030385 IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
    K001423 KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
    K001426 KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
    K001424 KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD