PMA
P090026: ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA PMA · P2psa · Beckman Coulter, Inc.
Key facts
| PMA number | P090026 |
|---|---|
| Trade name | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Generic name | P2psa |
| Applicant | Beckman Coulter, Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | OYA |
| Approval date | Jun 14, 2012 |
| Docket number | 12M-0638 |
| Notice date | Jun 20, 2012 |
| Establishment registration | 2122870 |
| FEI number | 2122870 |
At a glance
- 10–99 Supplements
- Jun 16, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: