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

    GREINER VACUETTE BLOOD COLLECTION TUBE

    K Number: K971221 · Decision May 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    K Number
    K971221
    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 2, 1997
    Product Code
    GIM
    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
    GIM Tubes, Vacuum Sample, With Anticoagulant

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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
    K971236 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