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

    IMMULITE(TM) TOTAL T4

    K Number: K910261 · Decision Apr 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    IMMULITE(TM) TOTAL T4
    K Number
    K910261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    January 22, 1991
    Decision Date
    April 16, 1991
    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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    Other Clearances by Cirrus Diagnostics, Inc.

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    K905648 CRP LIPID REAGENT TEST PACK
    K905214 IMMULITE (TM) TOTAL T3
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    K905215 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER