← Product Code [JFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT) · K954591

# AIA-PACK CORT ASSAY (K954591)

_Tosoh Medics, Inc. · JFT · Dec 15, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K954591

## Device Facts

- **Applicant:** Tosoh Medics, Inc.
- **Product Code:** [JFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT.md)
- **Decision Date:** Dec 15, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1205
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K954591](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K954591)

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