Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1175](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1175) → NFX — Test, Cholesterol, Total, Over The Counter

# NFX · Test, Cholesterol, Total, Over The Counter

_Clinical Chemistry · 21 CFR 862.1175 · Class 1_

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

## Overview

- **Product Code:** NFX
- **Device Name:** Test, Cholesterol, Total, Over The Counter
- **Regulation:** [21 CFR 862.1175](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1175)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K033899](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NFX/K033899.md) | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | May 20, 2004 | SESE |

## Top Applicants

- Lifestream Technologies, Inc. — 1 clearance

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

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