← Product Code [CIW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW) · K812027

# KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (K812027)

_Eastman Kodak Company · CIW · Aug 3, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K812027

## Device Facts

- **Applicant:** Eastman Kodak Company
- **Product Code:** [CIW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW.md)
- **Decision Date:** Aug 3, 1981
- **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/CIW/K812027](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K812027)

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