← Product Code [CGO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGO) · K780545

# SR-PLUS DIRECT CHOLESTEROL TEST (K780545)

_Stanbio Laboratory · CGO · May 26, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGO/K780545

## Device Facts

- **Applicant:** Stanbio Laboratory
- **Product Code:** [CGO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGO.md)
- **Decision Date:** May 26, 1978
- **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/CGO/K780545](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGO/K780545)

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