← Product Code [CGF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF) · K935013

# DSL ESTRONE (DSL 8700) (K935013)

_Diagnostic Systems Laboratories, Inc. · CGF · Jun 16, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF/K935013

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [CGF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF.md)
- **Decision Date:** Jun 16, 1994
- **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/K935013](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGF/K935013)

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