← Product Code [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT) · K863874

# LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (K863874)

_Electro-Nucleonics Laboratories, Inc. · CDT · Nov 13, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K863874

## Device Facts

- **Applicant:** Electro-Nucleonics Laboratories, Inc.
- **Product Code:** [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT.md)
- **Decision Date:** Nov 13, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1705
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K863874](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K863874)

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