← Product Code [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT) · K964346

# PARAMAX TRIGLYCERID REAGENT (K964346)

_Dade Intl., Inc. · CDT · Mar 28, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K964346

## Device Facts

- **Applicant:** Dade Intl., Inc.
- **Product Code:** [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT.md)
- **Decision Date:** Mar 28, 1997
- **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/K964346](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K964346)

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