DHEA TEST SET
Device Facts
| Record ID | K771793 |
|---|---|
| Device Name | DHEA TEST SET |
| Applicant | Wien Laboratories, Inc. |
| Product Code | CIY · Clinical Chemistry |
| Decision Date | Nov 2, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1080 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.
