PMA
P970038: TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · Beckman Coulter, Inc.
Key facts
| PMA number | P970038 |
|---|---|
| Trade name | TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | Beckman Coulter, Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | MTG |
| Approval date | Mar 10, 1998 |
| Docket number | 98M-0201 |
| Notice date | Apr 16, 1998 |
| Establishment registration | 2050012 |
| FEI number | 2050012 |
At a glance
- 10–99 Supplements
- May 15, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: