SERUM 11-DESOXYCORTISOL I AS TRACER
Device Facts
| Record ID | K791740 |
|---|---|
| Device Name | SERUM 11-DESOXYCORTISOL I AS TRACER |
| Applicant | Radioassay Systems Laboratories, Inc. |
| Product Code | JKB · Clinical Chemistry |
| Decision Date | Sep 27, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1185 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.
