← Product Code [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT) · K915732

# ABBOTT QUICKSTART TIGLYCERIDES REAGENT (K915732)

_Em Diagnostic Systems, Inc. · CDT · Jan 15, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K915732

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT.md)
- **Decision Date:** Jan 15, 1992
- **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/K915732](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K915732)

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