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

    VACUTAINER BRAND PPT PLASMA PREPARATION TUBE

    K Number: K972075 · Decision Feb 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    7
    Applicant Total
    15
    Review Days
    266

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    Basic Information

    Device Name
    VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
    K Number
    K972075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vacutainer Systems
    Date Received
    June 3, 1997
    Decision Date
    February 24, 1998
    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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