# MTG · Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

_ ·  · Class 3_

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

## Overview

- **Product Code:** MTG
- **Device Name:** Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250026](/device/P250026.md) | Atellica IM free PSA II (fPSAII) | Siemens Healthcare Diagnostics, Inc. | May 11, 2026 | APPR |
| [P080008](/device/P080008.md) | VIDAS FREE PSA RT ASSAY | bioMerieux, Inc. | Oct 8, 2009 | APWD |
| [P060005](/device/P060005.md) | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS | Siemens Medical Solutions Diagnostics Limited | May 11, 2007 | APPR |
| [P980007](/device/P980007.md) | AXSYM FREE PSA | Abbott Laboratories | Feb 5, 2004 | APPR |
| [P020027](/device/P020027.md) | DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS | Siemens Healthcare Diagnostics | Jan 24, 2003 | APPR |
| [P970038](/device/P970038.md) | TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | Mar 10, 1998 | APPR |
| [P950021](/device/P950021.md) | ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY | Siemens Healthcare Diagnostics | Dec 22, 1995 | APPR |

## Top Applicants

- Siemens Healthcare Diagnostics — 2 clearances
- Abbott Laboratories — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Siemens Healthcare Diagnostics, Inc. — 1 clearance
- Siemens Medical Solutions Diagnostics Limited — 1 clearance

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

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