JMD · Radioimmunoassay, Total Estrogens, Nonpregnancy
Clinical Chemistry · 21 CFR 862.1275 · Class 1
Overview
| Product Code | JMD |
|---|---|
| Device Name | Radioimmunoassay, Total Estrogens, Nonpregnancy |
| Regulation | 21 CFR 862.1275 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K791651 | TOTAL ESTROGENS KIT BY RIA | Radioassay Systems Laboratories, Inc. | Sep 27, 1979 | SESE |
| K781009 | ANALYZER, SERUM IRON & TOTAL IRON BINDIN | Environmental Sciences Assoc., Inc. | Jul 27, 1978 | SESE |
Top Applicants
- Environmental Sciences Assoc., Inc. — 1 clearance
- Radioassay Systems Laboratories, Inc. — 1 clearance
