← Product Code [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET) · K864438

# BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438)

_Beckman Instruments, Inc. · CET · Mar 12, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K864438

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET.md)
- **Decision Date:** Mar 12, 1987
- **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/CET/K864438](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K864438)

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