MTG · Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
· Class 3
Overview
| Product Code | MTG |
|---|---|
| Device Name | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250026 | Atellica IM free PSA II (fPSAII) | Siemens Healthcare Diagnostics, Inc. | May 11, 2026 | APPR |
| P080008 | VIDAS FREE PSA RT ASSAY | bioMerieux, Inc. | Oct 8, 2009 | APWD |
| P060005 | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS | Siemens Medical Solutions Diagnostics Limited | May 11, 2007 | APPR |
| P980007 | AXSYM FREE PSA | Abbott Laboratories | Feb 5, 2004 | APPR |
| P020027 | 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 | TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | Mar 10, 1998 | APPR |
| P950021 | 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
