# OYM · Prostrate Cancer Genes Nucleic Acid Amplification Test System

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/IM-misc/OYM

## Overview

- **Product Code:** OYM
- **Device Name:** Prostrate Cancer Genes Nucleic Acid Amplification Test System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P100033](https://fda.innolitics.com/submissions/IM/IM-misc/OYM/P100033.md) | PROGENSA PCA3 ASSAY | Gen-Probe Incorporated | Feb 13, 2012 | APWD |

## Top Applicants

- Gen-Probe Incorporated — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/IM-misc/OYM](https://fda.innolitics.com/submissions/IM/IM-misc/OYM)

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