- Device
- ARCHITECT Total PSA Reagent/Calibrator/Control Kit
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S052
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2020-04-10
- Decision code
- APPR
- Date received
- 2019-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to implement of new lot of ARCHITECT Total PSA Secondary Calibrators A through F.