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

    HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER

    K Number: K080384 · Decision Jun 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    21
    Applicant Total
    115
    Review Days
    114

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    Basic Information

    Device Name
    HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
    K Number
    K080384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    February 13, 2008
    Decision Date
    June 6, 2008
    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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