PMA P090026S018
- Device
- Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S018
- Product code
- OYA
- Decision date
- 2017-06-16
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- Approval for a modification to the UniCel Dxl Clinical System's sample probe to improve the manufacturability of the component.
Current openFDA PMA Record#
- Device
- Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S018
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2017-06-16
- Decision code
- APPR
- Date received
- 2017-03-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the UniCel Dxl Clinical System's sample probe to improve the manufacturability of the component.