BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ADVIA Centaur Calcitonin (CALCT) assay

    K Number: K182012 · Decision Dec 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    4
    Review Days
    147

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    Basic Information

    Device Name
    ADVIA Centaur Calcitonin (CALCT) assay
    K Number
    K182012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis-Shield Diagnostics Limited
    Date Received
    July 27, 2018
    Decision Date
    December 21, 2018
    Product Code
    JKR
    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
    JKR Radioimmunoassay, Calcitonin

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    K153551 ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
    K160757 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)