21 CFR 862.1430 — Zimmerman (Spectrophotometric), 17-Ketosteroids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1430
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCY | Zimmerman (Spectrophotometric), 17-Ketosteroids | 1 | 1 | |
| CDE | Chromatographic Separation/Zimmerman, 17-Ketosteroids | 1 | 0 |
