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

    Tina-quant Cystatin C Gen.2

    K Number: K161817 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    21
    Applicant Total
    14
    Review Days
    26

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    Basic Information

    Device Name
    Tina-quant Cystatin C Gen.2
    K Number
    K161817
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations (Rdo)
    Date Received
    July 1, 2016
    Decision Date
    July 27, 2016
    Product Code
    NDY
    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
    NDY Test, Cystatin C

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