BEUDAMED
    Product Code: CDG FDA class 1 21 CFR 862.1385

    Chromatography Separation/Zimmerman 17-Ketogenic Steroids

    Clinical Chemistry

    The Chromatography Separation/Zimmerman 17-Ketogenic Steroids Test is a clinical chemistry device that uses chromatographic separation combined with the Zimmerman colorimetric reaction to measure 17-ketogenic steroids in urine, providing a more specific assessment of adrenal corticosteroid metabolite excretion than non-separation methods. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDG, regulated under 21 CFR 862.1385, 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
    CDG
    Device Class
    FDA class 1
    Regulation Number
    862.1385
    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
    K772337 URINARY 17-KETOSTERIOD/17