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

    IMMULITE(R) FSH

    K Number: K921704 · Decision Jun 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    87
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    IMMULITE(R) FSH
    K Number
    K921704
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    April 10, 1992
    Decision Date
    June 9, 1992
    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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