PMA P930027S040

Device: IMMULITE Systems PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S040
Product code: MTF
Decision date: 2026-08-20
Classification: Immunology
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.

Current openFDA PMA Record#

Device: IMMULITE Systems PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S040
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2026-08-20
Decision code: OK30
Date received: 2026-07-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.