# OWE · Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/OWE

## Overview

- **Product Code:** OWE
- **Device Name:** Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens.  It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P110012](/device/P110012.md) | VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK | Abbott Molecular, Inc. | Aug 26, 2011 | APPR |

## Top Applicants

- Abbott Molecular, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/OWE](https://fda.innolitics.com/productcode/OWE)

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