← Product Code [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW) · K803296

# ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (K803296)

_Immunotech Corp. · KWW · Jan 16, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K803296

## Device Facts

- **Applicant:** Immunotech Corp.
- **Product Code:** [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW.md)
- **Decision Date:** Jan 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1177
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K803296](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K803296)

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