PMA P850048S060
- Device
- Access Hybritech PSA
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S060
- Product code
- MTF
- Decision date
- 2024-09-04
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Migration of the Access Hybritech PSA to the DxI 9000 Access Immunoassay Analyzer.
Current openFDA PMA Record#
- Device
- Access Hybritech PSA
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S060
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2024-09-04
- Decision code
- APPR
- Date received
- 2024-03-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Migration of the Access Hybritech PSA to the DxI 9000 Access Immunoassay Analyzer.