AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
Device Facts
| Record ID | K821678 |
|---|---|
| Device Name | AUTOPAK ESTRIOL TEST DELIVERY SYSTEM |
| Applicant | Micromedic Systems |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Jun 24, 1982 |
| 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.
