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

    VACUETTE® QUICKSHIELD Complete (Plus)

    K Number: K233979 · Decision Jul 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    10
    Review Days
    214

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    Basic Information

    Device Name
    VACUETTE® QUICKSHIELD Complete (Plus)
    K Number
    K233979
    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 North America, Inc.
    Date Received
    December 18, 2023
    Decision Date
    July 19, 2024
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HO
    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 North America, Inc.

    K Number Device Name
    K122687 BLOOD CULTURE HOLDER
    K121908 SAFETY INFUSION SET
    K113505 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
    K103041 VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
    K102774 VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
    K081929 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
    K072320 GREINER VACUETTE QUICKSHIELD COMPLETE
    K063357 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
    K061483 VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES