BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DS30 HCY BLOOD COLLECTION TUBES

    K Number: K012152 · Decision Sep 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    7
    Review Days
    69

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    Basic Information

    Device Name
    DS30 HCY BLOOD COLLECTION TUBES
    K Number
    K012152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Drew Scientific , Ltd.
    Date Received
    July 11, 2001
    Decision Date
    September 18, 2001
    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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