← Product Code [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS) · K954778

# CHOLESTECH LDX SYSTEM (K954778)

_Cholestech Corp. · LBS · Nov 24, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K954778

## Device Facts

- **Applicant:** Cholestech Corp.
- **Product Code:** [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS.md)
- **Decision Date:** Nov 24, 1995
- **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/K954778](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K954778)

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