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 862.1815](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1815) → JOB — Hexane Extraction, Fluorescence, Vitamin E

# JOB · Hexane Extraction, Fluorescence, Vitamin E

_Clinical Chemistry · 21 CFR 862.1815 · Class 1_

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

## Overview

- **Product Code:** JOB
- **Device Name:** Hexane Extraction, Fluorescence, Vitamin E
- **Regulation:** [21 CFR 862.1815](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1815)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.

## Classification Rationale

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

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932852](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JOB/K932852.md) | NON INVASIVE VASCULAR PROGRAM | D. E. Hokanson, Inc. | Feb 4, 1994 | SESE |

## Top Applicants

- D. E. Hokanson, Inc. — 1 clearance

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

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