# OYA · P2psa

_ ·  · Class 3_

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

## Overview

- **Product Code:** OYA
- **Device Name:** P2psa
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P090026](/device/P090026.md) | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | Jun 14, 2012 | APPR |

## Top Applicants

- Beckman Coulter, Inc. — 1 clearance

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

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