PMA P950021S026

Device: Atelica IM Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S026
Product code: MTG
Decision date: 2024-05-15
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: migration of the ADVIA Centaur PSA assay to the Atellica CI Analyzer

Current openFDA PMA Record#

Device: Atelica IM Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S026
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2024-05-15
Decision code: APPR
Date received: 2023-11-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: migration of the ADVIA Centaur PSA assay to the Atellica CI Analyzer