← Product Code [JID](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID) · K820723

# KODAK EKTACHEM CLINICAL CHEM. NH3 (K820723)

_Eastman Kodak Company · JID · Apr 1, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K820723

## Device Facts

- **Applicant:** Eastman Kodak Company
- **Product Code:** [JID](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID.md)
- **Decision Date:** Apr 1, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1065
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K820723](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K820723)

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