PMA P930027S037

Device: IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S037
Product code: MTF
Decision date: 2025-10-30
Classification: Immunology
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site.

Current openFDA PMA Record#

Device: IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S037
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2025-10-30
Decision code: OK30
Date received: 2025-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site.