← Product Code [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF) · K934925

# BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR (K934925)

_Beckman Instruments, Inc. · JIF · Apr 26, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K934925

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF.md)
- **Decision Date:** Apr 26, 1994
- **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/K934925](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K934925)

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