KETOSTEROID TEST, HYCEL-17
Device Facts
| Record ID | K782116 |
|---|---|
| Device Name | KETOSTEROID TEST, HYCEL-17 |
| Applicant | Hycel, Inc. |
| Product Code | CCY · Clinical Chemistry |
| Decision Date | Jan 26, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1430 |
| Device Class | Class 1 |
Regulatory Classification
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.
