← Product Code [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS) · K792183

# DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (K792183)

_Dade, Baxter Travenol Diagnostics, Inc. · LBS · Nov 13, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K792183

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [LBS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS.md)
- **Decision Date:** Nov 13, 1979
- **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/K792183](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBS/K792183)

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