← Product Code [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF) · K003196

# SYNCHRON SYSTEMS AMMONIA REAGENT (K003196)

_Beckman Coulter, Inc. · JIF · Dec 22, 2000 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K003196

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF.md)
- **Decision Date:** Dec 22, 2000
- **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/JIF/K003196](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K003196)

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