CGF · Radioimmunoassay, Estrone
Clinical Chemistry · 21 CFR 862.1280 · Class 1
Overview
| Product Code | CGF |
|---|---|
| Device Name | Radioimmunoassay, Estrone |
| Regulation | 21 CFR 862.1280 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970915 | DSL ESTRONE-SULFATE RIA | Diagnostic Systems Laboratories, Inc. | May 16, 1997 | SESE |
| K935013 | DSL ESTRONE (DSL 8700) | Diagnostic Systems Laboratories, Inc. | Jun 16, 1994 | SESE |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | Diagnostics Biochem Canada, Inc. | Jan 9, 1987 | SESE |
| K833406 | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | Corning Medical & Scientific | Jan 24, 1984 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 2 clearances
- Corning Medical & Scientific — 1 clearance
- Diagnostics Biochem Canada, Inc. — 1 clearance
