ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
Device Facts
| Record ID | K864966 |
|---|---|
| Device Name | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE |
| Applicant | Diagnostics Biochem Canada, Inc. |
| Product Code | CGF · Clinical Chemistry |
| Decision Date | Jan 9, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1280 |
| Device Class | Class 1 |
Regulatory Classification
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.
