← Product Code [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ) · K842960

# ANDROSTENEDIONE BY RIA (K842960)

_Radioassay Systems Laboratories, Inc. · CIZ · Sep 27, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K842960

## Device Facts

- **Applicant:** Radioassay Systems Laboratories, Inc.
- **Product Code:** [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ.md)
- **Decision Date:** Sep 27, 1984
- **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/K842960](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K842960)

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