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

    CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM

    K Number: K021428 · Decision Jul 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    48
    Applicant Total
    96
    Review Days
    63

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    Basic Information

    Device Name
    CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
    K Number
    K021428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    May 3, 2002
    Decision Date
    July 5, 2002
    Product Code
    JFY
    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
    JFY Enzymatic Method, Creatinine

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