← Product Code [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ) · K954755

# COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755)

_Diagnostic Products Corp. · CIZ · Nov 29, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K954755

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [CIZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ.md)
- **Decision Date:** Nov 29, 1995
- **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/K954755](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIZ/K954755)

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