← Product Code [JQB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB) · K823883

# ULTRAZYME PLUS GAMMA-GT, #64959/65032 (K823883)

_Emd Chemicals, Inc. · JQB · Jan 28, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K823883

## Device Facts

- **Applicant:** Emd Chemicals, Inc.
- **Product Code:** [JQB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB.md)
- **Decision Date:** Jan 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1360
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K823883](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K823883)

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