← Product Code [JQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN) · K863070

# FAST MUCOPROTEINS (K863070)

_J. D. Assoc. · JQN · Sep 11, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K863070

## Device Facts

- **Applicant:** J. D. Assoc.
- **Product Code:** [JQN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN.md)
- **Decision Date:** Sep 11, 1986
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K863070](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQN/K863070)

**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