← Product Code [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET) · K791922

# HARLECO BRAND CLINICARD LIPASE TEST SET (K791922)

_Dade, Baxter Travenol Diagnostics, Inc. · CET · Nov 27, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K791922

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET.md)
- **Decision Date:** Nov 27, 1979
- **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/K791922](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K791922)

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