PMA P930027S036

Device: IMMULITE 2000 Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S036
Product code: MTF
Decision date: 2025-08-14
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

Current openFDA PMA Record#

Device: IMMULITE 2000 Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S036
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2025-08-14
Decision code: OK30
Date received: 2025-07-18
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