BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TESTOSTERONE RADIOIMMUNOASSY KIT

    K Number: K802135 · Decision Oct 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    TESTOSTERONE RADIOIMMUNOASSY KIT
    K Number
    K802135
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioimmunoassay, Inc.
    Date Received
    September 4, 1980
    Decision Date
    October 10, 1980
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

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    Other Clearances by Radioimmunoassay, Inc.

    K Number Device Name
    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
    K780672 125 I-T4 RIA REAGENT