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

    T3 UPTAKE (T3U) REAGENTS

    K Number: K792607 · Decision Jan 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    44
    Review Days
    29

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    Basic Information

    Device Name
    T3 UPTAKE (T3U) REAGENTS
    K Number
    K792607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    December 18, 1979
    Decision Date
    January 16, 1980
    Product Code
    KHQ
    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
    KHQ Radioassay, Triiodothyronine Uptake

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    Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.

    K Number Device Name
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    K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
    K792723 BLOOD FLUID FILTERS
    K792443 TSH RADIOIMMUNOASSAY
    K792442 FERRITIN RADIOIMMUNOASSAY
    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
    K790571 QUIK-STAIN
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →