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

    D-10 Hemoglobin A1c Program

    K Number: K161687 · Decision Oct 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    82
    Review Days
    119

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    Basic Information

    Device Name
    D-10 Hemoglobin A1c Program
    K Number
    K161687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1373
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    June 17, 2016
    Decision Date
    October 14, 2016
    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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