PMA
P850048: TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Beckman Coulter, Inc.
Key facts
| PMA number | P850048 |
|---|---|
| Trade name | TANDEM-R PSA IMMUNORADIOMETRIC ASSAY |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Beckman Coulter, Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | MTF |
| Approval date | Feb 25, 1986 |
| Docket number | 86M-0137 |
| Notice date | Apr 9, 1986 |
| Establishment registration | 2050012 |
| FEI number | 2050012 |
At a glance
- 10–99 Supplements
- Sep 4, 2024 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- No Withdrawn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: