← Product Code [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ) · K872023

# AMYLASE TEST KIT (K872023)

_Ciba Corning Diagnostics Corp. · JFJ · Aug 5, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K872023

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ.md)
- **Decision Date:** Aug 5, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1070
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K872023](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K872023)

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