← Product Code [JIA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA) · K951329

# IMMUCHEM GAL-MW EA (K951329)

_Icn Pharmaceuticals, Inc. · JIA · Nov 9, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K951329

## Device Facts

- **Applicant:** Icn Pharmaceuticals, Inc.
- **Product Code:** [JIA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA.md)
- **Decision Date:** Nov 9, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1310
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K951329](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K951329)

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