← Product Code [CGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGS) · K780100

# ULTRAZYME PLUS CK-1 (K780100)

_Harleco · CGS · Mar 9, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGS/K780100

## Device Facts

- **Applicant:** Harleco
- **Product Code:** [CGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGS.md)
- **Decision Date:** Mar 9, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1215
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and 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/CGS/K780100](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGS/K780100)

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