← Product Code [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET) · K940457

# LIPASE REAGENT SYSTEM (K940457)

_Medical Diagnostic Technologies, Inc. · CET · Jun 2, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K940457

## Device Facts

- **Applicant:** Medical Diagnostic Technologies, Inc.
- **Product Code:** [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET.md)
- **Decision Date:** Jun 2, 1994
- **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/K940457](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K940457)

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