← Product Code [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT) · K852010

# TGL REAGENT (K852010)

_Alpkem Corp. · CDT · May 30, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K852010

## Device Facts

- **Applicant:** Alpkem Corp.
- **Product Code:** [CDT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT.md)
- **Decision Date:** May 30, 1985
- **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/K852010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDT/K852010)

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