← Product Code [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI) · K920337

# MILES LIPASE SERA-PAK METHOD (K920337)

_Heraeus Kulzer, Inc. · CHI · Mar 11, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K920337

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI.md)
- **Decision Date:** Mar 11, 1992
- **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/K920337](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K920337)

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