|Trade Name||DIMENSION TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Applicant||SIEMENS HEALTHCARE DIAGNOSTICS INC.|
|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.