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

    ACCUWELL T4-EIA

    K Number: K972974 · Decision Oct 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    21
    Review Days
    56

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    Basic Information

    Device Name
    ACCUWELL T4-EIA
    K Number
    K972974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neometrics, Inc.
    Date Received
    August 11, 1997
    Decision Date
    October 6, 1997
    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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