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

    IMMULITE(TM) T-UPTAKE

    K Number: K910677 · Decision Apr 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    73

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    Basic Information

    Device Name
    IMMULITE(TM) T-UPTAKE
    K Number
    K910677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    February 15, 1991
    Decision Date
    April 29, 1991
    Product Code
    CEE
    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
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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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
    K905769 IMMULITE HS-TSH
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