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

    ENXYMATIC CREATININE TEST

    K Number: K812095 · Decision Aug 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    48
    Applicant Total
    340
    Review Days
    38

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    Basic Information

    Device Name
    ENXYMATIC CREATININE TEST
    K Number
    K812095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    July 24, 1981
    Decision Date
    August 31, 1981
    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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