Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070) → CIK — Radial Diffusion, Amylase

# CIK · Radial Diffusion, Amylase

_Clinical Chemistry · 21 CFR 862.1070 · Class 2_

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

## Overview

- **Product Code:** CIK
- **Device Name:** Radial Diffusion, Amylase
- **Regulation:** [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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).

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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