← Product Code [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR) · K830207

# RAICHEM HDL-CHOLESTEROL REAGENT (K830207)

_Reagents Applications, Inc. · LBR · Mar 21, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K830207

## Device Facts

- **Applicant:** Reagents Applications, Inc.
- **Product Code:** [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR.md)
- **Decision Date:** Mar 21, 1983
- **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/K830207](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K830207)

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