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

    ADVIA Centaur Erythropoietin (EPO) assay

    K Number: K183088 · Decision Aug 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    4
    Review Days
    269

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    Basic Information

    Device Name
    ADVIA Centaur Erythropoietin (EPO) assay
    K Number
    K183088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis-Shield Diagnostics Limited
    Date Received
    November 6, 2018
    Decision Date
    August 2, 2019
    Product Code
    GGT
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGT Assay, Erythropoietin

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    Other Clearances by Axis-Shield Diagnostics Limited

    K Number Device Name
    K182012 ADVIA Centaur Calcitonin (CALCT) assay
    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)