# P230015: Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC

- Pathway: PMA
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 17, 2025 after 914 days
- Product code: LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen))
- Device class: 2
- Regulation: 21 CFR 866.3172
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P230015
Methodology: https://510kreport.com/methodology