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

    ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17

    K Number: K912807 · Decision Oct 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    48
    Applicant Total
    288
    Review Days
    128

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    Basic Information

    Device Name
    ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
    K Number
    K912807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    June 25, 1991
    Decision Date
    October 31, 1991
    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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