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

    VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR

    K Number: K081929 · Decision Dec 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    10
    Review Days
    162

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    Basic Information

    Device Name
    VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
    K Number
    K081929
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greiner Bio-One North America, Inc.
    Date Received
    July 7, 2008
    Decision Date
    December 16, 2008
    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 North America, Inc.

    K Number Device Name
    K233979 VACUETTE® QUICKSHIELD Complete (Plus)
    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
    K072320 GREINER VACUETTE QUICKSHIELD COMPLETE
    K063357 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
    K061483 VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES