PMA P850048S051
- Device
- Access Hybritech PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S051
- Product code
- MTF
- Decision date
- 2019-07-31
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Approval for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.
Current openFDA PMA Record#
- Device
- Access Hybritech PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S051
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2019-07-31
- Decision code
- APPR
- Date received
- 2019-05-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.