BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ELECSYS T4 CALCHECK 5

    K Number: K112528 · Decision Oct 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    ELECSYS T4 CALCHECK 5
    K Number
    K112528
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corporation
    Date Received
    August 31, 2011
    Decision Date
    October 18, 2011
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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