← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K811760

# CHOLESTEROL DETERMINATION (K811760)

_Biorent Diagnostic, Inc. · CHH · Jul 10, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K811760

## Device Facts

- **Applicant:** Biorent Diagnostic, Inc.
- **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md)
- **Decision Date:** Jul 10, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1175
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K811760](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K811760)

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