← Product Code [JKC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC) · K842555

# DHEA-S DIRECT RIA KIT (K842555)

_Biotecx Laboratories, Inc. · JKC · Aug 7, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K842555

## Device Facts

- **Applicant:** Biotecx Laboratories, Inc.
- **Product Code:** [JKC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC.md)
- **Decision Date:** Aug 7, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1245
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K842555](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K842555)

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