← Product Code [CJA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA) · K884226

# AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226)

_A-Kem, Inc. · CJA · Dec 9, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K884226

## Device Facts

- **Applicant:** A-Kem, Inc.
- **Product Code:** [CJA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA.md)
- **Decision Date:** Dec 9, 1988
- **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/CJA/K884226](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K884226)

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