← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K890990

# EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE (K890990)

_Hichem Diagnostics · CHH · Apr 10, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K890990

## Device Facts

- **Applicant:** Hichem Diagnostics
- **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md)
- **Decision Date:** Apr 10, 1989
- **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/K890990](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K890990)

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