← Product Code [CHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP) · K933464

# STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464)

_Baxter Diagnostics, Inc. · CHP · Oct 22, 1993 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP/K933464

## Device Facts

- **Applicant:** Baxter Diagnostics, Inc.
- **Product Code:** [CHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP.md)
- **Decision Date:** Oct 22, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1260
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP/K933464](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP/K933464)

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