← Product Code [CCZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCZ) · K760348

# REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 (K760348)

_Sigma Chemical Co. · CCZ · Oct 27, 1976 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCZ/K760348

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [CCZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCZ.md)
- **Decision Date:** Oct 27, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1385
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCZ/K760348](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCZ/K760348)

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