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

    COBAS (R) CORE T4 EIA

    K Number: K932605 · Decision Jan 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    85
    Applicant Total
    296
    Review Days
    241

    Basic Information

    Device Name
    COBAS (R) CORE T4 EIA
    K Number
    K932605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Received
    May 28, 1993
    Decision Date
    January 24, 1994
    Product Code
    KLI
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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