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

    SYRINGE FOR BLOOD SAMPLING

    K Number: K803182 · Decision Jan 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    31

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    Basic Information

    Device Name
    SYRINGE FOR BLOOD SAMPLING
    K Number
    K803182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The University of Chicago
    Date Received
    December 16, 1980
    Decision Date
    January 16, 1981
    Product Code
    GIM
    Advisory Committee
    Clinical Chemistry
    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
    GIM Tubes, Vacuum Sample, With Anticoagulant

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    Other Clearances by The University of Chicago

    K Number Device Name
    K803302 PREHEPARINZED SYRINGE