← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K855187

# ENZYMATIC CHOLESTROL REAGENT SET (K855187)

_Technostics Intl. · CHH · Jan 14, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K855187

## Device Facts

- **Applicant:** Technostics Intl.
- **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md)
- **Decision Date:** Jan 14, 1986
- **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/K855187](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K855187)

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