← Product Code [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI) · K874027

# LIPASE UV [TOYO] (K874027)

_Advocacy International, Ltd. · CHI · May 27, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K874027

## Device Facts

- **Applicant:** Advocacy International, Ltd.
- **Product Code:** [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI.md)
- **Decision Date:** May 27, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1465
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K874027](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K874027)

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