PMA P090026
- Device
- Access Hybritech p2PSA
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S031
- Product code
- OYA
- Decision date
- 2025-06-16
- Generic name
- P2psa
- Approval order statement
- migration of the Access Hybritech p2PSA Reagents to the Dxl 9000 Access Immunoassay Analyzer
Current openFDA PMA Record#
- Device
- Access Hybritech p2PSA
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S032
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2025-06-16
- Decision code
- APPR
- Date received
- 2024-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- migration of the Access Hybritech p2PSA Reagents to the Dxl 9000 Access Immunoassay Analyzer