ANALYZER, SERUM IRON & TOTAL IRON BINDIN
Device Facts
| Record ID | K781009 |
|---|---|
| Device Name | ANALYZER, SERUM IRON & TOTAL IRON BINDIN |
| Applicant | Environmental Sciences Assoc., Inc. |
| Product Code | JMD · Clinical Chemistry |
| Decision Date | Jul 27, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1275 |
| Device Class | Class 1 |
Regulatory Classification
Identification
As estrogens (total, nonpregnancy) test system is a device intended to measure the level of estrogens (total estrone, estradiol, and estriol) in plasma, serum, and urine of males and nonpregnant females. Measurement of estrogens (total, nonpregnancy) is used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea (absence of menses) differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
