← Product Code [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS) · K895851

# SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT (K895851)

_Beckman Instruments, Inc. · LBS · Nov 29, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K895851

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS.md)
- **Decision Date:** Nov 29, 1989
- **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/LBS/K895851](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K895851)

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