← Product Code [KLJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLJ) · K770577

# DETER. OF PHOSPHOHEXOSE ISOMERASE (K770577)

_Sigma Chemical Co. · KLJ · Jun 17, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLJ/K770577

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [KLJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLJ.md)
- **Decision Date:** Jun 17, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1570
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohexose isomerase in serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLJ/K770577](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLJ/K770577)

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