CIY · Radioimmunoassay, Androsterone
Clinical Chemistry · 21 CFR 862.1080 · Class 1
Overview
| Product Code | CIY |
|---|---|
| Device Name | Radioimmunoassay, Androsterone |
| Regulation | 21 CFR 862.1080 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771793 | DHEA TEST SET | Wien Laboratories, Inc. | Nov 2, 1977 | SESE |
Top Applicants
- Wien Laboratories, Inc. — 1 clearance
