← Product Code [JMD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMD) · K781009

# ANALYZER, SERUM IRON & TOTAL IRON BINDIN (K781009)

_Environmental Sciences Assoc., Inc. · JMD · Jul 27, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMD/K781009

## Device Facts

- **Applicant:** Environmental Sciences Assoc., Inc.
- **Product Code:** [JMD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMD.md)
- **Decision Date:** Jul 27, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1275
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMD/K781009](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMD/K781009)

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