MTF · Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
· Class 3
Overview
| Product Code | MTF |
|---|---|
| Device Name | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240021 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | Dec 3, 2025 | APPR |
| P170037 | Sangia Total PSA Test | Opko Diagnostics, LLC | Jan 30, 2019 | APWD |
| P040008 | VIDAS TPSA ASSAY | bioMerieux, Inc. | Jul 8, 2004 | APWD |
| P990056 | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | Nov 22, 2000 | APPR |
| P930027 | IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS | Siemens Healthcare Diagnostics, Inc. | Sep 15, 1995 | APPR |
| P910065 | AIA-PACK PSA | Tosoh Bioscience, Inc. | Jul 7, 1993 | APPR |
| P910007 | AXSYM TOTAL PSA & ARCHITECT TOTAL PSA | Abbott Laboratories | Sep 25, 1991 | APPR |
| P850048 | TANDEM-R PSA IMMUNORADIOMETRIC ASSAY | Beckman Coulter, Inc. | Feb 25, 1986 | APPR |
Top Applicants
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Opko Diagnostics, LLC — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
