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) → JLG — Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids

# JLG · Conversion To Ferric Hydroxymates (Colorimetric), 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/JLG

## Overview

- **Product Code:** JLG
- **Device Name:** Conversion To Ferric Hydroxymates (Colorimetric), 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K812081](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLG/K812081.md) | WAKO NEFA C TEST | Wako Chemicals USA, Inc. | Aug 12, 1981 | SESE |
| [K760750](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLG/K760750.md) | STERILE TUBULAR UNBLEACHED STOCKINETTE | Dennison Manufacturing Co. | Oct 8, 1976 | SESE |

## Top Applicants

- Dennison Manufacturing Co. — 1 clearance
- Wako Chemicals USA, Inc. — 1 clearance

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

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