← Product Code [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ) · K945243

# CATALOGUE NUMBER 321-07/15/50 (K945243)

_Diagnostic Chemicals , Ltd. · JFJ · Feb 8, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K945243

## Device Facts

- **Applicant:** Diagnostic Chemicals , Ltd.
- **Product Code:** [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ.md)
- **Decision Date:** Feb 8, 1995
- **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/K945243](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K945243)

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