← Product Code [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR) · K911906

# MAGNETIC HDL CHOLESTEROL TEST (K911906)

_Reference Diagnostics, Inc. · LBR · Jul 18, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K911906

## Device Facts

- **Applicant:** Reference Diagnostics, Inc.
- **Product Code:** [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR.md)
- **Decision Date:** Jul 18, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1475
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K911906](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K911906)

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