PMA P980007S052
- Device
- Alinity i Free PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S052
- Product code
- MTG
- Decision date
- 2023-09-25
- Classification
- Immunology
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Approval for the release of Alinity i Free PSA for use with Alinity ci-series.
Current openFDA PMA Record#
- Device
- Alinity i Free PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S052
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- 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 Free PSA for use with Alinity ci-series.