PMA P910007S067
- Device
- ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S067
- Product code
- MTF
- Decision date
- 2026-02-12
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- change to a new supplier of a manufacturing ingredient
Current openFDA PMA Record#
- Device
- ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S067
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2026-02-12
- Decision code
- OK30
- Date received
- 2026-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change to a new supplier of a manufacturing ingredient