BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COBAS INTEGRA CHOLESTEROL GEN. 2

    K Number: K031824 · Decision Jul 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    264
    Review Days
    26

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    Basic Information

    Device Name
    COBAS INTEGRA CHOLESTEROL GEN. 2
    K Number
    K031824
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    June 13, 2003
    Decision Date
    July 9, 2003
    Product Code
    CHH
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

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