CCY · Zimmerman (Spectrophotometric), 17-Ketosteroids
Clinical Chemistry · 21 CFR 862.1430 · Class 1
Overview
| Product Code | CCY |
|---|---|
| Device Name | Zimmerman (Spectrophotometric), 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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K782116 | KETOSTEROID TEST, HYCEL-17 | Hycel, Inc. | Jan 26, 1979 | SESE |
Top Applicants
- Hycel, Inc. — 1 clearance
