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

    125 I-T4 RIA REAGENT

    K Number: K780672 · Decision Jun 6, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    9
    Review Days
    43

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    Basic Information

    Device Name
    125 I-T4 RIA REAGENT
    K Number
    K780672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioimmunoassay, Inc.
    Date Received
    April 24, 1978
    Decision Date
    June 6, 1978
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Radioimmunoassay, Inc.

    K Number Device Name
    K802135 TESTOSTERONE RADIOIMMUNOASSY KIT
    K800106 LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
    K800107 FOLLICLE STIMULATING HORMONE
    K792539 TRIIODOTHYRONINE RIA SYSTEM
    K792153 DIGOXIN RADIOIMMUNOASSAY SYSTEM
    K792154 THYROID STIMULATING HORMONE
    K792036 CORTISOL RADIOIMMUNOASSAY SYSTEM
    K780671 125 I-T3 UPTAKE REAGENT