PMA P060005

Device: IMMULITE 2000 Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S016
Product code: MTG
Decision date: 2026-07-27
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S025
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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.