PMA P910007S065
- Device
- ARCHITECT Total PSA / Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S065
- Product code
- MTF
- Decision date
- 2023-12-14
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- a scale up of manufacturing processes for kit components
Current openFDA PMA Record#
- Device
- ARCHITECT Total PSA / Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S065
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2023-12-14
- Decision code
- OK30
- Date received
- 2023-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a scale up of manufacturing processes for kit components