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

    VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE

    K Number: K944566 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    230
    Applicant Total
    632
    Review Days
    50

    Basic Information

    Device Name
    VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
    K Number
    K944566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    September 21, 1994
    Decision Date
    November 10, 1994
    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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