← Product Code [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI) · K822314

# DSL 1400 (K822314)

_Diagnostic Systems Laboratories, Inc. · CGI · Sep 30, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K822314

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI.md)
- **Decision Date:** Sep 30, 1982
- **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/K822314](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K822314)

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