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 862.1470](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1470) → CFB — Chromatographic Derivative, Total Lipids

# CFB · Chromatographic Derivative, Total Lipids

_Clinical Chemistry · 21 CFR 862.1470 · Class 1_

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

## Overview

- **Product Code:** CFB
- **Device Name:** Chromatographic Derivative, Total Lipids
- **Regulation:** [21 CFR 862.1470](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1470)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.

## 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 the limitations in § 862.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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