|Trade Name||ARCHITECT TOTAL PSA ASSAY|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||immunochemistry analyzer|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for migration of the architect total psa assay to a new architect i system family member, the architect i1000sr.