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

    VACUETTE EVACUATED BLOOD COLLECTION TUBES

    K Number: K011699 · Decision Jun 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    VACUETTE EVACUATED BLOOD COLLECTION TUBES
    K Number
    K011699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greiner Bio-One Vacuette North America
    Date Received
    June 1, 2001
    Decision Date
    June 28, 2001
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Greiner Bio-One Vacuette North America

    K Number Device Name
    K080235 SAFETY INFUSION SET
    K042927 VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
    K033478 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
    K023971 VACUETTE TRACE ELEMENTS TUBES