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

    I-STAT CARDIAC TROPONIN (CTNI) TEST

    K Number: K031739 · Decision Sep 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    94
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    I-STAT CARDIAC TROPONIN (CTNI) TEST
    K Number
    K031739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    June 4, 2003
    Decision Date
    September 2, 2003
    Product Code
    MMI
    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
    MMI Immunoassay Method, Troponin Subunit

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