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

    FDTX GLUCOSE CONTROL SOLUTION

    K Number: K081915 · Decision Aug 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    FDTX GLUCOSE CONTROL SOLUTION
    K Number
    K081915
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics Texas, Inc.
    Date Received
    July 3, 2008
    Decision Date
    August 8, 2008
    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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    Other Clearances by Fujirebio Diagnostics Texas, Inc.

    K Number Device Name
    K080273 AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION