- Device
- ARCHITECT Free PSA, Alinity i Free PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S049
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2023-10-11
- Decision code
- APPR
- Date received
- 2023-02-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the formulation change for the common accessories, Pre-Trigger and Trigger, and storage condition changes for Pre-Trigger used on ARCHITECT i2000SR, ARCHITECT i1000SR and Alinity i analyzer