PMA P910007S058
- Device
- ARCHITECT Total PSA / Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S058
- Product code
- MTF
- Decision date
- 2022-10-12
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Add an additional supplier for a kit component.
Current openFDA PMA Record#
- Device
- ARCHITECT Total PSA / Alinity i Total PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S058
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2022-10-12
- Decision code
- OK30
- Date received
- 2022-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional supplier for a kit component.