PMA P930027S039

Device: IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S039
Product code: MTF
Decision date: 2026-07-27
Classification: Immunology
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: Approval of the change to in-process manufacturing quality testing for the IMMULITE 2000 XPi analyzers and IMMULITE 2000 / IMMULITE 2000 XPi spare probe assemblies.

Current openFDA PMA Record#

Device: IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S039
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2026-07-27
Decision code: OK30
Date received: 2026-06-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the change to in-process manufacturing quality testing for the IMMULITE 2000 XPi analyzers and IMMULITE 2000 / IMMULITE 2000 XPi spare probe assemblies.