← Product Code [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI) · K897150

# LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150)

_Toyo Jozo Co., Ltd. · CHI · Feb 26, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K897150

## Device Facts

- **Applicant:** Toyo Jozo Co., Ltd.
- **Product Code:** [CHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI.md)
- **Decision Date:** Feb 26, 1990
- **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/K897150](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHI/K897150)

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