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

    CUSTOMED BLOOD EXTRACTION KIT

    K Number: K962596 · Decision Sep 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    36
    Review Days
    87

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    Basic Information

    Device Name
    CUSTOMED BLOOD EXTRACTION KIT
    K Number
    K962596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Customed, Inc.
    Date Received
    July 2, 1996
    Decision Date
    September 27, 1996
    Product Code
    GJE
    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
    GJE Tray, Blood Collection

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