← Product Code [JKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKB) · K791740

# SERUM 11-DESOXYCORTISOL I AS TRACER (K791740)

_Radioassay Systems Laboratories, Inc. · JKB · Sep 27, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKB/K791740

## Device Facts

- **Applicant:** Radioassay Systems Laboratories, Inc.
- **Product Code:** [JKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKB.md)
- **Decision Date:** Sep 27, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1185
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKB/K791740](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKB/K791740)

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