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

    AIACT KIT

    K Number: K032952 · Decision Dec 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    AIACT KIT
    K Number
    K032952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sienco, Inc.
    Date Received
    September 22, 2003
    Decision Date
    December 12, 2003
    Product Code
    JBP
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JBP Activated Whole Blood Clotting Time

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