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

    T3 UPTAKE RADIOIMMUNOASSAY KIT

    K Number: K791361 · Decision Aug 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    9
    Review Days
    27

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    Basic Information

    Device Name
    T3 UPTAKE RADIOIMMUNOASSAY KIT
    K Number
    K791361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technia Diagnostics , Ltd.
    Date Received
    July 20, 1979
    Decision Date
    August 16, 1979
    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 Technia Diagnostics , Ltd.

    K Number Device Name
    K861978 AUTOFLUOR V
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    K801202 DIGOXIN RADIOIMMUNOASSAY KIT
    K801203 CORTISOL RADIOIMMUNOASSAY KIT
    K790919 HPL RIA KIT
    K790495 THYROXINE RIA KIT
    K782024 RIA KIT, VITAMIN B12
    K782025 GENTAMICIN FLUROIMMUNASSAY KIT