← Product Code [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW) · K781337

# CONJUGATED BILE ACIDS RIA KIT (K781337)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · KWW · Aug 11, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K781337

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [KWW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW.md)
- **Decision Date:** Aug 11, 1978
- **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/K781337](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K781337)

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