← Product Code [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF) · K932556

# AMMONIA ASSAY CAT. NO. 200-02 (K932556)

_Diagnostic Chemicals, Ltd. (Usa) · JIF · Aug 2, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K932556

## Device Facts

- **Applicant:** Diagnostic Chemicals, Ltd. (Usa)
- **Product Code:** [JIF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF.md)
- **Decision Date:** Aug 2, 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/K932556](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIF/K932556)

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