← Product Code [JMK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMK) · K780104

# ULTRAZYME PLUS HBD (K780104)

_Harleco · JMK · Feb 13, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMK/K780104

## Device Facts

- **Applicant:** Harleco
- **Product Code:** [JMK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMK.md)
- **Decision Date:** Feb 13, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1380
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMK/K780104](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMK/K780104)

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