CDE · Chromatographic Separation/Zimmerman, 17-Ketosteroids
Clinical Chemistry · 21 CFR 862.1430 · Class 1
Overview
| Product Code | CDE |
|---|---|
| Device Name | Chromatographic Separation/Zimmerman, 17-Ketosteroids |
| Regulation | 21 CFR 862.1430 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (0)
No cleared devices on record.
