← Product Code [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF) · K913124

# ROCHE REAGENT FOR AMMONIA (K913124)

_Roche Diagnostic Systems, Inc. · JIF · Aug 12, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K913124

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF.md)
- **Decision Date:** Aug 12, 1991
- **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/K913124](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K913124)

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