PMA P020027S041

Device: Dimension FPSA Flex reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P020027
Supplement: S041
Product code: MTG
Decision date: 2025-02-24
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Transfer of Assembling & Packaging Aligned Source Lamp Assembly Service Spare Part used in the Dimension Family of Instruments to Existing Supplier.

Current openFDA PMA Record#

Device: Dimension FPSA Flex reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P020027
Supplement: S041
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2025-02-24
Decision code: OK30
Date received: 2025-01-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of Assembling & Packaging Aligned Source Lamp Assembly Service Spare Part used in the Dimension Family of Instruments to Existing Supplier.