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

    FERTELL FEMALE FERTILITY TEST

    K Number: K032002 · Decision Oct 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    FERTELL FEMALE FERTILITY TEST
    K Number
    K032002
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genosis, Inc.
    Date Received
    June 27, 2003
    Decision Date
    October 30, 2003
    Product Code
    NGA
    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
    NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter

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