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

    GREINER VACUETTE BLOOD COLLECTION TUBE

    K Number: K971236 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    K Number
    K971236
    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 America, Inc.
    Date Received
    April 2, 1997
    Decision Date
    May 12, 1997
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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 America, Inc.

    K Number Device Name
    K971220 GREINER VACUETTE BLOOD COLLECTION TUBE
    K971239 GREINER VACUETTE BLOOD COLLECTION TUBE
    K971221 GREINER VACUETTE BLOOD COLLECTION TUBE
    K960860 GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
    K960857 GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
    K960858 GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR