- Device
- Alinity i Free PSA assay
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S041
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2020-06-05
- Decision code
- APPR
- Date received
- 2017-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the migration of the Abbott ARCHITECT Free PSA assay to the Alinity i Analyzer.