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

    VACUGUARD(TM)

    K Number: K880594 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    VACUGUARD(TM)
    K Number
    K880594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Habley Medical Technology Corp.
    Date Received
    February 11, 1988
    Decision Date
    April 28, 1988
    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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