← Product Code [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG) · K850882

# ACTH II BY RADIOIMMUNOASSAY (K850882)

_Immuno Nuclear Corp. · CKG · Mar 21, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K850882

## Device Facts

- **Applicant:** Immuno Nuclear Corp.
- **Product Code:** [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG.md)
- **Decision Date:** Mar 21, 1985
- **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/K850882](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K850882)

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