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 862.1290](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1290) → JLH — Titrimetric, Fatty Acids

# JLH · Titrimetric, Fatty Acids

_Clinical Chemistry · 21 CFR 862.1290 · Class 1_

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

## Overview

- **Product Code:** JLH
- **Device Name:** Titrimetric, Fatty Acids
- **Regulation:** [21 CFR 862.1290](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1290)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K792555](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLH/K792555.md) | ELVI NON-ESTERIFIED FATTY ACIDS | Volu Sol Medical Industries | Jan 16, 1980 | SESE |

## Top Applicants

- Volu Sol Medical Industries — 1 clearance

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

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