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

    TROPONIN (TROP) METHOD

    K Number: K973650 · Decision Oct 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    94
    Applicant Total
    13
    Review Days
    25

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    Basic Information

    Device Name
    TROPONIN (TROP) METHOD
    K Number
    K973650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Chemistry Systems, Inc.
    Date Received
    September 25, 1997
    Decision Date
    October 20, 1997
    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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