← Product Code [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG) · K910178

# ACTH IRMA KIT MITSUBISHI YUKA (K910178)

_Science Regulatory Services Intl. · CKG · May 22, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K910178

## Device Facts

- **Applicant:** Science Regulatory Services Intl.
- **Product Code:** [CKG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG.md)
- **Decision Date:** May 22, 1991
- **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/K910178](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKG/K910178)

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