← Product Code [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ) · K001086

# FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (K001086)

_Diagnostic Systems Laboratories, Inc. · CDZ · May 18, 2000 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K001086

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ.md)
- **Decision Date:** May 18, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1680
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K001086](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K001086)

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