- Device
- Access Hybritech PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S053
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2020-03-17
- Decision code
- APPR
- Date received
- 2019-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification to the UniCel DxI Immunoassay System’s pick and place gantries.