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

    I-STAT KAOLIN ACT TEST

    K Number: K023582 · Decision Sep 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    319

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    Basic Information

    Device Name
    I-STAT KAOLIN ACT TEST
    K Number
    K023582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    October 24, 2002
    Decision Date
    September 8, 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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