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 862.1040](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1040) → CJC — Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase

# CJC · Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase

_Clinical Chemistry · 21 CFR 862.1040 · Class 1_

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

## Overview

- **Product Code:** CJC
- **Device Name:** Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
- **Regulation:** [21 CFR 862.1040](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1040)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

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

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