PMA P950021S027

Device: ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S027
Product code: MTG
Decision date: 2023-12-18
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Reduce the microbial testing performed on non-sterile, lyophilized in vitro diagnostic devices.

Current openFDA PMA Record#

Device: ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S027
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2023-12-18
Decision code: OK30
Date received: 2023-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the microbial testing performed on non-sterile, lyophilized in vitro diagnostic devices.