- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S041
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- 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 the modification to the UniCel DxI Immunoassay Systems pick and place gantries.