ANDROSTENEDIONE TEST SET 125I
Device Facts
| Record ID | K832452 |
|---|---|
| Device Name | ANDROSTENEDIONE TEST SET 125I |
| Applicant | Wien Laboratories, Inc. |
| Product Code | CIZ · Clinical Chemistry |
| Decision Date | Sep 12, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1075 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.
