PMA P910007S063
- Device
- Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S063
- Product code
- MTF
- Decision date
- 2023-09-25
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Approval for the release of Alinity i Total PSA for use with Alinity ci-series.
Current openFDA PMA Record#
- Device
- Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S063
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2023-09-25
- Decision code
- APPR
- Date received
- 2023-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the release of Alinity i Total PSA for use with Alinity ci-series.