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

    VACUETTE EDTA K2 TUBES

    K Number: K014104 · Decision Feb 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    VACUETTE EDTA K2 TUBES
    K Number
    K014104
    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 Vacuette North America, Inc.
    Date Received
    December 13, 2001
    Decision Date
    February 1, 2002
    Product Code
    PJE
    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
    PJE Blood/Plasma Collection Device For Dna Testing

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    Other Clearances by Greiner Vacuette North America, Inc.

    K Number Device Name
    K012043 VACUETTE EDTA K2 GEL TUBES
    K011786 VACUETTE SAFETY BLOOD COLLECTION SET
    K003812 VACUETTE SPEEDY QUICK-RELEASE HOLDER
    K002777 VACUETTE WITH PPACK