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

    CONE-TROL LIQUID CHEMISTRY CONTROLS

    K Number: K121759 · Decision Jul 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    3
    Review Days
    39

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    Basic Information

    Device Name
    CONE-TROL LIQUID CHEMISTRY CONTROLS
    K Number
    K121759
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cone Bioproducts
    Date Received
    June 15, 2012
    Decision Date
    July 24, 2012
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Cone Bioproducts

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    K121534 CONE-TROL HEMOGLOBIN A1C CONTROL SET
    K052010 HBA1C LINEARITY SET