← Product Code [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW) · K970120

# BILE ACIDS REAGENT SET (K970120)

_Teco Diagnostics · KWW · Mar 24, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K970120

## Device Facts

- **Applicant:** Teco Diagnostics
- **Product Code:** [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW.md)
- **Decision Date:** Mar 24, 1997
- **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/K970120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K970120)

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