PMA P060005S023

Device: IMMULITE 2000 Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S023
Product code: MTG
Decision date: 2025-10-30
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S023
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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.