← Product Code [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI) · K791728

# RSL'S ASSAY PROCEDURE QUANTITATION (K791728)

_Radioassay Systems Laboratories, Inc. · CGI · Sep 27, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K791728

## Device Facts

- **Applicant:** Radioassay Systems Laboratories, Inc.
- **Product Code:** [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI.md)
- **Decision Date:** Sep 27, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1265
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K791728](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K791728)

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