← Product Code [JQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN) · K792554

# ELVI MUCAPROTEINS (K792554)

_Volu Sol Medical Industries · JQN · Jan 16, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K792554

## Device Facts

- **Applicant:** Volu Sol Medical Industries
- **Product Code:** [JQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN.md)
- **Decision Date:** Jan 16, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1505
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K792554](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K792554)

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