|Trade Name||DIMENSION FPSA FLEX REAGENT CARTRIDGE|
|Classification Name||test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions|
|Generic Name||prostate specific antigen (psa) for detection and management of prostate cancers|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software revision that changes the operating system of the instrument from the current qnx operating system to the linux operating system and addresses hardware obsolescence issues.