# PKW · Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

_ ·  · Class 3_

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

## Overview

- **Product Code:** PKW
- **Device Name:** Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens.  The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P140025](/device/P140025.md) | VENTANA ALK (D5F3) CDX ASSAY | Ventana Medical Systems, Inc. | Jun 12, 2015 | APPR |

## Top Applicants

- Ventana Medical Systems, Inc. — 1 clearance

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

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