COAT-A-COUNT DIRECT ANDROSTENEDIONE
Device Facts
| Record ID | K954755 |
|---|---|
| Device Name | COAT-A-COUNT DIRECT ANDROSTENEDIONE |
| Applicant | Diagnostic Products Corp. |
| Product Code | CIZ · Clinical Chemistry |
| Decision Date | Nov 29, 1995 |
| 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.
