← Product Code [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET) · K823860

# NUCLIPASE (I125) PANCREATIC LIPASE (K823860)

_Nuclear Diagnostics, Inc. · CET · Apr 18, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K823860

## Device Facts

- **Applicant:** Nuclear Diagnostics, Inc.
- **Product Code:** [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET.md)
- **Decision Date:** Apr 18, 1983
- **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/K823860](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K823860)

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