PMA
P230015: Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Beckman Coulter, Inc.
Key facts
| PMA number | P230015 |
|---|---|
| Trade name | Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Beckman Coulter, Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | LOM |
| Approval date | Oct 17, 2025 |
| Establishment registration | 2050012 |
| FEI number | 2050012 |
At a glance
- None Supplements
- Oct 17, 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- No Withdrawn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: