← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K801285

# YSI MODELS 23C & 23CM HDL & TOTAL CHOLES (K801285)

_Yellow Springs Instrument Co., Inc. · CHH · Jul 28, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K801285

## Device Facts

- **Applicant:** Yellow Springs Instrument Co., Inc.
- **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md)
- **Decision Date:** Jul 28, 1980
- **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/K801285](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K801285)

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