← Product Code [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG) · K831855

# HATCH KIT (K831855)

_Radioassay Systems Laboratories, Inc. · CKG · Jul 28, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K831855

## Device Facts

- **Applicant:** Radioassay Systems Laboratories, Inc.
- **Product Code:** [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG.md)
- **Decision Date:** Jul 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1025
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K831855](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K831855)

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