# PNK · Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

_ ·  · Class 3_

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

## Overview

- **Product Code:** PNK
- **Device Name:** Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150041](/device/P150041.md) | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | Apr 11, 2016 | APPR |

## Top Applicants

- Abbott Molecular, Inc. — 1 clearance

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

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