DSL ESTRONE (DSL 8700)
Device Facts
| Record ID | K935013 |
|---|---|
| Device Name | DSL ESTRONE (DSL 8700) |
| Applicant | Diagnostic Systems Laboratories, Inc. |
| Product Code | CGF · Clinical Chemistry |
| Decision Date | Jun 16, 1994 |
| 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.
