BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Tina-quant Hemoglobin A1cDx Gen.3

    K Number: K193053 · Decision Mar 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    14
    Review Days
    146

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    Basic Information

    Device Name
    Tina-quant Hemoglobin A1cDx Gen.3
    K Number
    K193053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1373
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations (Rdo)
    Date Received
    November 1, 2019
    Decision Date
    March 26, 2020
    Product Code
    PDJ
    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
    PDJ Hemoglobin A1c Test System

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