DSL 1900
Device Facts
| Record ID | K830816 |
|---|---|
| Device Name | DSL 1900 |
| Applicant | Diagnostic Systems |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Apr 12, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1265 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
