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

    GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

    K Number: K080662 · Decision May 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    66

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    Basic Information

    Device Name
    GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
    K Number
    K080662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Corporation
    Date Received
    March 10, 2008
    Decision Date
    May 15, 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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