← Product Code [CJT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJT) · K760821

# REAGENT SYSTEM (K760821)

_Sigma Chemical Co. · CJT · Oct 21, 1976 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJT/K760821

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [CJT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJT.md)
- **Decision Date:** Oct 21, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1040
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJT/K760821](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJT/K760821)

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