← Product Code [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW) · K872296

# BILE ACIDS REAGENT (K872296)

_Sigma Diagnostics, Inc. · KWW · Aug 26, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K872296

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW.md)
- **Decision Date:** Aug 26, 1987
- **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/K872296](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K872296)

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