|Trade Name||ARCHITECT TOTAL PSA (LN 6C06)|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||immunochemistry analyzer|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the quality control testing of architect free psa panels g/i, architect total psa panel stock and architect total psa panels k/q.