PMA P930027S041
- Device
- IMMULITE Systems PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S041
- Product code
- MTF
- Decision date
- 2026-09-22
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- to move manufacturing of a critical component within the same facility
Current openFDA PMA Record#
- Device
- IMMULITE Systems PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S041
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2026-09-22
- Decision code
- OK30
- Date received
- 2026-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to move manufacturing of a critical component within the same facility