← Product Code [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR) · K881326

# HDL CHOLESTEROL PRECIPITATING PROCEDURE (K881326)

_Data Medical Associates, Inc. · LBR · May 27, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K881326

## Device Facts

- **Applicant:** Data Medical Associates, Inc.
- **Product Code:** [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR.md)
- **Decision Date:** May 27, 1988
- **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/K881326](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K881326)

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