← Product Code [JID](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID) · K813366

# AMMONIA TEST (K813366)

_Wako Pure Chemical Industries, Ltd. · JID · Dec 22, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K813366

## Device Facts

- **Applicant:** Wako Pure Chemical Industries, Ltd.
- **Product Code:** [JID](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID.md)
- **Decision Date:** Dec 22, 1981
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K813366](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JID/K813366)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com