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

    FREE T3 RADIOIMMUNOASSAY KIT

    K Number: K862968 · Decision Sep 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    9
    Review Days
    50

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    Basic Information

    Device Name
    FREE T3 RADIOIMMUNOASSAY KIT
    K Number
    K862968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bioclinical Group
    Date Received
    August 6, 1986
    Decision Date
    September 25, 1986
    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 Bioclinical Group

    K Number Device Name
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    K823004 BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
    K822840 RADIOIMMUNOASSAY, HUMAN CHORRIONIC
    K822515 B-HCG RADIOIMMUNOASSAY KIT
    K821241 FREE T4 RADIOIMMUNOASSAY KIT
    K821101 TOTAL RADIOIMMUNOASSAY KIT