|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ARCHITECT TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||immunochemistry analyzer|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Revision of the quality control test method to allow the axsym total and free psa test methods to be replaced by the architect total and free psa test methods for the manufacture of psa panel h.