JKB · Radioimmunoassay, Compound S (11-Deoxycortisol)
Clinical Chemistry · 21 CFR 862.1185 · Class 1
Overview
| Product Code | JKB |
|---|---|
| Device Name | Radioimmunoassay, Compound S (11-Deoxycortisol) |
| Regulation | 21 CFR 862.1185 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Radioassay Systems Laboratories, Inc. | Sep 27, 1979 | SESE |
Top Applicants
- Radioassay Systems Laboratories, Inc. — 1 clearance
