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 862.1180](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1180) → JKW — N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin

# JKW · N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin

_Clinical Chemistry · 21 CFR 862.1180 · Class 1_

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

## Overview

- **Product Code:** JKW
- **Device Name:** N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
- **Regulation:** [21 CFR 862.1180](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1180)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A chymotrypsin test system is a device intended to measure the activity of the enzyme chymotrypsin in blood and other body fluids and in feces. Chymotrypsin measurements are used in the diagnosis and treatment of pancreatic exocrine insufficiency.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## 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/JKW](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKW)

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