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

    CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY

    K Number: K872286 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    125
    Review Days
    35

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    Basic Information

    Device Name
    CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
    K Number
    K872286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    June 16, 1987
    Decision Date
    July 21, 1987
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Ciba Corning Diagnostics Corp.

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    K961657 CIBA CORNING 400 SYSTEM
    K962021 CIBA CORNING 348 SYSTEM
    K962126 ACS CKMB II IMMUNOASSAY
    K962041 ACS LH2 IMMUNOASSAY
    K961510 ACS FRT4 IMMUNOASSAY
    K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    K955873 ACS PHENYTOIN ASSAY
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