← Product Code [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ) · K854650

# DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650)

_Diagnostic Systems Laboratories, Inc. · CIZ · Dec 13, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K854650

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ.md)
- **Decision Date:** Dec 13, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1075
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K854650](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K854650)

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