← Product Code [CHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP) · K970643

# VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)

_Johnson & Johnson Clinical Diagnostics, Inc. · CHP · Mar 18, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP/K970643

## Device Facts

- **Applicant:** Johnson & Johnson Clinical Diagnostics, Inc.
- **Product Code:** [CHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP.md)
- **Decision Date:** Mar 18, 1997
- **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/K970643](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHP/K970643)

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