BEUDAMED
    Product Code: CCY FDA class 1 21 CFR 862.1430

    Zimmerman (Spectrophotometric), 17-Ketosteroids

    Clinical Chemistry

    The Zimmerman Spectrophotometric 17-Ketosteroids Test is a clinical chemistry device that uses spectrophotometric measurement based on the Zimmerman reaction to quantify 17-ketosteroid levels in biological specimens, used to assess adrenal and gonadal androgen production. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCY, regulated under 21 CFR 862.1430, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    CCY
    Device Class
    FDA class 1
    Regulation Number
    862.1430
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K782116 KETOSTEROID TEST, HYCEL-17