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

    FOLLICLE STIMULATING HORMONE

    K Number: K800107 · Decision Feb 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    87
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    FOLLICLE STIMULATING HORMONE
    K Number
    K800107
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioimmunoassay, Inc.
    Date Received
    January 16, 1980
    Decision Date
    February 13, 1980
    Product Code
    CGJ
    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
    CGJ Radioimmunoassay, Follicle-Stimulating Hormone

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    Other Clearances by Radioimmunoassay, Inc.

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    K792036 CORTISOL RADIOIMMUNOASSAY SYSTEM
    K780671 125 I-T3 UPTAKE REAGENT
    K780672 125 I-T4 RIA REAGENT