← Product Code [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ) · K823402

# ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& (K823402)

_Emd Chemicals, Inc. · CDQ · Dec 26, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K823402

## Device Facts

- **Applicant:** Emd Chemicals, Inc.
- **Product Code:** [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ.md)
- **Decision Date:** Dec 26, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1770
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K823402](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K823402)

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