PMA P020027S040

Device: Dimension® FPSA Flex® reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P020027
Supplement: S040
Product code: MTG
Decision date: 2023-09-26
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Addition of alternate optical filters for 405nm and 452nm wavelengths used in Photometer Assembly on the Dimension Family of Instruments.

Current openFDA PMA Record#

Device: Dimension® FPSA Flex® reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P020027
Supplement: S040
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2023-09-26
Decision code: OK30
Date received: 2023-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of alternate optical filters for 405nm and 452nm wavelengths used in Photometer Assembly on the Dimension Family of Instruments.