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

    BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

    K Number: K933939 · Decision Feb 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    130
    Review Days
    179

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    Basic Information

    Device Name
    BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
    K Number
    K933939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Organon Teknika Corp.
    Date Received
    August 12, 1993
    Decision Date
    February 7, 1994
    Product Code
    GIM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    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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