← Product Code [CGF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF) · K864966

# ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966)

_Diagnostics Biochem Canada, Inc. · CGF · Jan 9, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF/K864966

## Device Facts

- **Applicant:** Diagnostics Biochem Canada, Inc.
- **Product Code:** [CGF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF.md)
- **Decision Date:** Jan 9, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1280
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, 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/CGF/K864966](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF/K864966)

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