← Product Code [JHO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO) · K871319

# TITAN GEL MULTI-SLOT LIPO-17 SYSTEM (K871319)

_Helena Laboratories · JHO · Apr 22, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO/K871319

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JHO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO.md)
- **Decision Date:** Apr 22, 1987
- **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/JHO/K871319](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO/K871319)

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