BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    ONE STEP FSH MENOPAUSAL TEST

    K Number: K052662 · Decision Nov 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    ONE STEP FSH MENOPAUSAL TEST
    K Number
    K052662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostic, Inc.
    Date Received
    September 27, 2005
    Decision Date
    November 30, 2005
    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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